# Jada System (intrauterine vacuum device) Product · id `maternal:jada-system` · Maternal & Newborn Atlas · release `c7fb95f1d15a7d13` (public) > General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here. The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations. Browse, life stage: Childbirth; Postpartum Browse, care area: Recovery after birth ## In plain language A device placed inside the uterus (womb) after birth that uses vacuum, instead of a filled balloon, to press on the uterine walls. In the United States, FDA cleared it in 2020, an updated version in 2021 and a version from a new applicant in 2026 through the 510(k) route, which means FDA found it substantially equivalent to a device already on the market. Its cleared use is "control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted". ## Technical summary Alydia Health (K201199, K212757) and Organon, LLC (K253642). 510(k) K201199, decision Substantially Equivalent on 2020-08-28, traditional clearance, product code OQY, regulation 21 CFR 884.4530, class II; Special 510(k) K212757, 2021-09-30, for an updated version with modifications to manufacturability, packaging and user experience; and Traditional 510(k) K253642, 2026-05-15, for Jada System (Jada-2002), with K212757 as predicate. All three state the same indication, quoted on this page. The K201199 summary names an earlier balloon device, cleared under K170622, as the predicate and says the compressed intrauterine loop is inserted transvaginally. The clearances cover that use only. Whether further Jada clearances exist beyond the three read here was not checked. ## Claims, with the population each applies to ## Context: Abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted, US 510(k) clearance of the Jada System (K201199) Recipient: Maternal; Population: Women with abnormal postpartum uterine bleeding or hemorrhage for whom conservative management is warranted. The cleared use is control and treatment of that bleeding (510(k) Indications for Use). It is not cleared for other uses.; Care setting: Not stated in the source; Geography: United States (FDA clearance); Life stage: After birth, abnormal postpartum uterine bleeding; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context) ### FDA cleared the Jada System from applicant Alydia Health under 510(k) K201199, with the decision Substantially Equivalent dated 2020-08-28. The Indications for Use state that the device is "intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted". The product code is OQY (openFDA name: Intrauterine Tamponade Balloon), the regulation is 21 CFR 884.4530 and the device class is II. The 510(k) summary names the Bakri Postpartum Balloon (K170622) as the predicate and says the Jada System uses vacuum to affect tamponade on the uterine walls, where the predicate uses the fluid pressure of an expanding balloon. - Category: Regulatory - Evidence stage: Evidence stage not applicable - Certainty: Certainty not assessed - Applies to: Recipient: Maternal; Population: Women with abnormal postpartum uterine bleeding or hemorrhage for whom conservative management is warranted. The cleared use is control and treatment of that bleeding (510(k) Indications for Use). It is not cleared for other uses.; Care setting: Not stated in the source; Geography: United States (FDA clearance); Life stage: After birth, abnormal postpartum uterine bleeding; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context) - Limitations: Clearance means FDA found the device substantially equivalent to a legally marketed predicate; it is not an approval and not a recommendation to use the device for any woman. Only the clearance letter, the Indications for Use form, the 510(k) summary and the openFDA record were read; contraindications, warnings and performance data were not. The openFDA record is the dataset copy as of its update date. - Last checked: 2026-10-15 - Sources: 1. Supports: FDA 510(k) premarket notification K201199: Jada System (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh\_docs/pdf20/K201199.pdf), read as default pdftotext text, which gives the cleared indication.) Locator: results\[0\].decision\_date and results\[0\].decision\_description. Retrieved 2026-10-15T13:49:17Z. Source state: Current. Snapshot hash: d6320d7d9ba80c9f4f3831e6c27410d5e205124215f9bb1a7d851518860c016b. How it applies: openFDA 510(k) JSON, CC0. 2. Supports: FDA 510(k) premarket notification K201199: Jada System (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh\_docs/pdf20/K201199.pdf), read as default pdftotext text, which gives the cleared indication.) Locator: results\[0\].product\_code and results\[0\].openfda.device\_name. Retrieved 2026-10-15T13:49:17Z. Source state: Current. Snapshot hash: d6320d7d9ba80c9f4f3831e6c27410d5e205124215f9bb1a7d851518860c016b. How it applies: openFDA 510(k) JSON, CC0. 3. Supports: FDA 510(k) premarket notification K201199: Jada System (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh\_docs/pdf20/K201199.pdf), read as default pdftotext text, which gives the cleared indication.) Locator: Indications for Use form and section V. Retrieved 2026-10-15T13:53:05Z. Source state: Current. Snapshot hash: e732bb54b770ec10af4bc60e70923156b554478b727c126ece4e7c403cb18f37. How it applies: 510(k) summary PDF released by FDA; short quotation. 4. Supports: FDA 510(k) premarket notification K201199: Jada System (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh\_docs/pdf20/K201199.pdf), read as default pdftotext text, which gives the cleared indication.) Locator: Section VI, technological differences. Retrieved 2026-10-15T13:53:05Z. Source state: Current. Snapshot hash: e732bb54b770ec10af4bc60e70923156b554478b727c126ece4e7c403cb18f37. How it applies: 510(k) summary PDF released by FDA; short quotation. ## Context: Abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted, US 510(k) clearance of the updated Jada System (K212757) Recipient: Maternal; Population: The same population as the earlier Jada System clearance: women with abnormal postpartum uterine bleeding or hemorrhage for whom conservative management is warranted. FDA treated the indication as identical to that of the earlier Jada System.; Care setting: Not stated in the source; Geography: United States (FDA clearance); Life stage: After birth, abnormal postpartum uterine bleeding; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context) ### FDA cleared an updated Jada System from applicant Alydia Health under Special 510(k) K212757, with the decision Substantially Equivalent dated 2021-09-30. The Indications for Use are the same as for the earlier Jada System clearance: "intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted". The summary says the subject device is an updated version of the earlier Jada System with modifications to improve manufacturability, streamline packaging and improve user experience and aesthetics. The product code is OQY and the device class is II. - Category: Regulatory - Evidence stage: Evidence stage not applicable - Certainty: Certainty not assessed - Applies to: Recipient: Maternal; Population: The same population as the earlier Jada System clearance: women with abnormal postpartum uterine bleeding or hemorrhage for whom conservative management is warranted. FDA treated the indication as identical to that of the earlier Jada System.; Care setting: Not stated in the source; Geography: United States (FDA clearance); Life stage: After birth, abnormal postpartum uterine bleeding; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context) - Limitations: Clearance means FDA found the device substantially equivalent to a legally marketed predicate; it is not an approval and not a recommendation to use the device for any woman. Only the clearance letter, the Indications for Use form, the 510(k) summary and the openFDA record were read; contraindications, warnings and performance data were not. The openFDA record is the dataset copy as of its update date. - Last checked: 2026-10-15 - Sources: 1. Supports: FDA 510(k) premarket notification K212757: Jada System (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh\_docs/pdf21/K212757.pdf), read as default pdftotext text, which gives the cleared indication.) Locator: results\[0\].decision\_date and results\[0\].decision\_description. Retrieved 2026-10-15T13:49:18Z. Source state: Current. Snapshot hash: a48a6d679e7c0426a5f24578c369020c9d8de844ffd654998a9418477f40d64c. How it applies: openFDA 510(k) JSON, CC0. 2. Supports: FDA 510(k) premarket notification K212757: Jada System (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh\_docs/pdf21/K212757.pdf), read as default pdftotext text, which gives the cleared indication.) Locator: results\[0\].product\_code and results\[0\].openfda.device\_name. Retrieved 2026-10-15T13:49:18Z. Source state: Current. Snapshot hash: a48a6d679e7c0426a5f24578c369020c9d8de844ffd654998a9418477f40d64c. How it applies: openFDA 510(k) JSON, CC0. 3. Supports: FDA 510(k) premarket notification K212757: Jada System (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh\_docs/pdf21/K212757.pdf), read as default pdftotext text, which gives the cleared indication.) Locator: Section V, Indications for Use. Retrieved 2026-10-15T13:53:05Z. Source state: Current. Snapshot hash: 708f770b0e7ca61e79cc88fc48023c9ebcfb593edb5650563e475c2234b6443c. How it applies: 510(k) summary PDF released by FDA; short quotation. 4. Supports: FDA 510(k) premarket notification K212757: Jada System (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh\_docs/pdf21/K212757.pdf), read as default pdftotext text, which gives the cleared indication.) Locator: Section VI. Retrieved 2026-10-15T13:53:05Z. Source state: Current. Snapshot hash: 708f770b0e7ca61e79cc88fc48023c9ebcfb593edb5650563e475c2234b6443c. How it applies: 510(k) summary PDF released by FDA; short quotation. ## Context: Abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted, US 510(k) clearance of the Jada System (Jada-2002), K253642 Recipient: Maternal; Population: The same population as the earlier Jada System clearances: women with abnormal postpartum uterine bleeding or hemorrhage for whom conservative management is warranted. FDA treated the indication as identical to that of the predicate, K212757.; Care setting: Not stated in the source; Geography: United States (FDA clearance); Life stage: After birth, abnormal postpartum uterine bleeding; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context) ### FDA cleared the Jada System (Jada-2002) from applicant Organon, LLC under Traditional 510(k) K253642, with the decision Substantially Equivalent dated 2026-05-15. The Indications for Use are the same as for the earlier Jada System clearances: "intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted". The summary names the Jada System cleared under K212757 as the predicate and says the subject and predicate have identical indications for use statements. The product code is OQY and the device class is II. - Category: Regulatory - Evidence stage: Evidence stage not applicable - Certainty: Certainty not assessed - Applies to: Recipient: Maternal; Population: The same population as the earlier Jada System clearances: women with abnormal postpartum uterine bleeding or hemorrhage for whom conservative management is warranted. FDA treated the indication as identical to that of the predicate, K212757.; Care setting: Not stated in the source; Geography: United States (FDA clearance); Life stage: After birth, abnormal postpartum uterine bleeding; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context) - Limitations: Clearance means FDA found the device substantially equivalent to a legally marketed predicate; it is not an approval and not a recommendation to use the device for any woman. Only the clearance letter, the Indications for Use form, the 510(k) summary and the openFDA record were read; contraindications, warnings and performance data were not. The openFDA record is the dataset copy as of its update date. - Last checked: 2026-10-15 - Sources: 1. Supports: FDA 510(k) premarket notification K253642: Jada System (Jada-2002) (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh\_docs/pdf25/K253642.pdf), read as default pdftotext text, which gives the cleared indication.) Locator: results\[0\].decision\_date and results\[0\].decision\_description. Retrieved 2026-10-15T14:46:48Z. Source state: Current. Snapshot hash: 15454869ec8e2928768ccccdc4dfc98d7e89b6d77a56c650fc458b35c1fabac9. How it applies: openFDA 510(k) JSON, CC0. 2. Supports: FDA 510(k) premarket notification K253642: Jada System (Jada-2002) (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh\_docs/pdf25/K253642.pdf), read as default pdftotext text, which gives the cleared indication.) Locator: results\[0\].product\_code and results\[0\].openfda.device\_name. Retrieved 2026-10-15T14:46:48Z. Source state: Current. Snapshot hash: 15454869ec8e2928768ccccdc4dfc98d7e89b6d77a56c650fc458b35c1fabac9. How it applies: openFDA 510(k) JSON, CC0. 3. Supports: FDA 510(k) premarket notification K253642: Jada System (Jada-2002) (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh\_docs/pdf25/K253642.pdf), read as default pdftotext text, which gives the cleared indication.) Locator: Indications for Use form and section V. Retrieved 2026-10-15T14:46:52Z. Source state: Current. Snapshot hash: 83b50ee59392910ed046a9782225dfeeff9f431e0fc2e5e796375ec8e92b6bfa. How it applies: 510(k) summary PDF released by FDA; short quotation. 4. Supports: FDA 510(k) premarket notification K253642: Jada System (Jada-2002) (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh\_docs/pdf25/K253642.pdf), read as default pdftotext text, which gives the cleared indication.) Locator: Predicate Device. Retrieved 2026-10-15T14:46:52Z. Source state: Current. Snapshot hash: 83b50ee59392910ed046a9782225dfeeff9f431e0fc2e5e796375ec8e92b6bfa. How it applies: 510(k) summary PDF released by FDA; short quotation. 5. Supports: FDA 510(k) premarket notification K253642: Jada System (Jada-2002) (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh\_docs/pdf25/K253642.pdf), read as default pdftotext text, which gives the cleared indication.) Locator: Section VI. Retrieved 2026-10-15T14:46:52Z. Source state: Current. Snapshot hash: 83b50ee59392910ed046a9782225dfeeff9f431e0fc2e5e796375ec8e92b6bfa. How it applies: 510(k) summary PDF released by FDA; short quotation. ## Guidance, authorization and access ### Regulatory decision `maternal:regdec-fda-k201199` - Product: Jada System (intrauterine vacuum device) (`maternal:jada-system`) - Authority: U.S. Food and Drug Administration (`core:fda`) - Decision: Clearance, 2020-08-28 - Product version: Jada System as cleared under K201199 (traditional 510(k)) - Pathway: 510(k) - Submission: K201199 - Product code: OQY - Device class: II - Indication: Cleared intended use, as the Indications for Use word it: "intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted". - Jurisdictions: United States; note: United States - Applies to: Recipient: Maternal; Population: Women with abnormal postpartum uterine bleeding or hemorrhage for whom conservative management is warranted. The cleared use is control and treatment of that bleeding (510(k) Indications for Use). It is not cleared for other uses.; Care setting: Not stated in the source; Geography: United States (FDA clearance); Life stage: After birth, abnormal postpartum uterine bleeding; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context) - Basis: claim `maternal:claim-fda-k201199-indication` ### Regulatory decision `maternal:regdec-fda-k212757` - Product: Jada System (intrauterine vacuum device) (`maternal:jada-system`) - Authority: U.S. Food and Drug Administration (`core:fda`) - Decision: Clearance, 2021-09-30 - Product version: Updated Jada System as cleared under K212757 (special 510(k)) - Pathway: 510(k) - Submission: K212757 - Product code: OQY - Device class: II - Indication: Cleared intended use, identical to the earlier Jada System: "intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted". - Jurisdictions: United States; note: United States - Applies to: Recipient: Maternal; Population: The same population as the earlier Jada System clearance: women with abnormal postpartum uterine bleeding or hemorrhage for whom conservative management is warranted. FDA treated the indication as identical to that of the earlier Jada System.; Care setting: Not stated in the source; Geography: United States (FDA clearance); Life stage: After birth, abnormal postpartum uterine bleeding; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context) - Basis: claim `maternal:claim-fda-k212757-indication` ### Regulatory decision `maternal:regdec-fda-k253642` - Product: Jada System (intrauterine vacuum device) (`maternal:jada-system`) - Authority: U.S. Food and Drug Administration (`core:fda`) - Decision: Clearance, 2026-05-15 - Product version: Jada System (Jada-2002) as cleared under K253642 (traditional 510(k)) - Pathway: 510(k) - Submission: K253642 - Product code: OQY - Device class: II - Indication: Cleared intended use, identical to the earlier Jada System: "intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted". - Jurisdictions: United States; note: United States - Applies to: Recipient: Maternal; Population: The same population as the earlier Jada System clearances: women with abnormal postpartum uterine bleeding or hemorrhage for whom conservative management is warranted. FDA treated the indication as identical to that of the predicate, K212757.; Care setting: Not stated in the source; Geography: United States (FDA clearance); Life stage: After birth, abnormal postpartum uterine bleeding; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context) - Basis: claim `maternal:claim-fda-k253642-indication` ## Connected pages - Vacuum-induced tamponade: Uterine balloon or vacuum tamponade for postpartum haemorrhage (`maternal:uterine-balloon-tamponade`) - Filed under this front: Procedures and birth care (`maternal:front-procedures-and-birth-care`) ## Provenance Content hash: bf924e7adb5c89eb128d8c76568143f33a8f2593df58f6587c1edcbfce322670 Last substantive edit: 2026-10-15 Evidence last checked: 2026-10-15