# SNOO Smart Sleeper (infant bassinet with supine-position system) Product · id `maternal:snoo-smart-sleeper` · Maternal & Newborn Atlas · release `fc5a600ec7387e71` (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: Infant follow-up Browse, care area: The baby's first year ## In plain language A bassinet with a swaddle-style Sleep Sack that clips to the bassinet to keep a baby on the back during sleep, with sound and motion. In 2023 FDA authorised it for babies from birth to 6 months who cannot yet roll over, for use at home. FDA says it has not been shown directly to reduce SIDS or sudden unexpected infant death. ## Technical summary FDA De Novo DEN210039 granted 2023-03-30 (openFDA), applicant Happiest Baby, Inc., product code QTG, Class II. It created the device type infant supine sleep system (21 CFR 880.5690) with special controls. The summary describes a bassinet and Sleep Sack jointly intended to facilitate a supine position during sleep for infants from birth to 6 months who cannot yet roll over consistently, and lists limits: not for infants who can push up on hands and knees or roll over consistently, not a substitute for adult supervision. The company reported supine position in about 98.7% of 1012 users and, among 106,723 users, no increase in reported SIDS or SUID against historical data; FDA found the data not good enough for a precise rate and required a postmarket surveillance study. The authorisation covers supine positioning, not prevention of SIDS or SUID. The recipient is the infant. ## Claims, with the population each applies to ## Context: Infants from birth to 6 months who cannot yet roll over consistently, home use (SNOO Smart Sleeper, United States) Recipient: Child; Population: Infants from birth to 6 months of age who are not yet able to roll over consistently, cared for at home by caregivers.; Care setting: Home use by caregivers.; Geography: United States (FDA); Life stage: Newborn and young infant, birth to 6 months of age; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context) ### FDA granted De Novo request DEN210039 for the SNOO Smart Sleeper on 30 March 2023 (openFDA decision date) and classified the new device type, the infant supine sleep system (21 CFR 880.5690), as Class II. FDA's summary says the bassinet and its Sleep Sack are jointly intended to help an infant stay on the back during sleep, for home use by caregivers of infants from birth to 6 months of age who cannot yet roll over consistently. FDA's summary also says the device has not directly demonstrated a reduction in the incidence of SIDS or SUID, so the labeling must carry a warning that the device has not been demonstrated to reduce that risk. - Category: Regulatory - Evidence stage: Evidence stage not applicable - Certainty: Certainty not assessed - Applies to: Recipient: Child; Population: Infants from birth to 6 months of age who are not yet able to roll over consistently, cared for at home by caregivers.; Care setting: Home use by caregivers.; Geography: United States (FDA); Life stage: Newborn and young infant, birth to 6 months of age; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context) - Limitations: The authorisation covers helping an infant stay in a supine sleep position within the stated age and ability limits. It does not cover prevention of SIDS or SUID, and FDA says so. The company's real-world data reported a supine position in about 98.7% of 1012 users and, in 106,723 users, no increase in reported SIDS or SUID against historical national data; FDA said the data were not good enough to give a precise SIDS or SUID rate, and required a postmarket surveillance study in higher-risk US subpopulations. A De Novo grant is not a recommendation to use the device, and safe sleep advice from public health sources is recorded separately on the safe infant sleep page. The text layer of the FDA PDF prints the device name inconsistently, with a zero in some places, and quotations repeat it as extracted. - Last checked: 2026-10-14 - Sources: 1. Supports: FDA De Novo DEN210039: SNOO Smart Sleeper (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05.) Locator: results\[0\].decision\_date. Retrieved 2026-10-14T18:18:26Z. Source state: Current. Snapshot hash: ecac6edf131ec217a5b7b09aeff9c71ffb94bff13b4e43a2436a02cb2a98151e. How it applies: Decision date in openFDA. 2. Supports: FDA De Novo DEN210039: SNOO Smart Sleeper (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05.) Locator: results\[0\].k\_number. Retrieved 2026-10-14T18:18:26Z. Source state: Current. Snapshot hash: ecac6edf131ec217a5b7b09aeff9c71ffb94bff13b4e43a2436a02cb2a98151e. How it applies: De Novo number in openFDA. 3. Supports: FDA De Novo DEN210039: SNOO Smart Sleeper (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05.) Locator: results\[0\].product\_code. Retrieved 2026-10-14T18:18:26Z. Source state: Current. Snapshot hash: ecac6edf131ec217a5b7b09aeff9c71ffb94bff13b4e43a2436a02cb2a98151e. How it applies: Product code in openFDA. 4. Supports: De Novo classification request for SNOO Smart Sleeper (DEN210039), decision summary (Regulator, edition The decision summary PDF, 8 pages, fetched on 2026-10-14. Its text layer prints the device name inconsistently (SNOO in some places and SNO0, with a zero, in others); quotations repeat the text exactly as extracted. The accessdata denovo.cfm page was fetched too (mj-fda-denovo-page-DEN210039.html) and was not used.) Locator: Regulatory information, generic type. Retrieved 2026-10-14T18:24:12Z. Source state: Current. Snapshot hash: f1f923890f7894cba63b75965ba5f303404ed1c74db0afa51d93c799aa182af6. How it applies: FDA description of the device type. 5. Supports: De Novo classification request for SNOO Smart Sleeper (DEN210039), decision summary (Regulator, edition The decision summary PDF, 8 pages, fetched on 2026-10-14. Its text layer prints the device name inconsistently (SNOO in some places and SNO0, with a zero, in others); quotations repeat the text exactly as extracted. The accessdata denovo.cfm page was fetched too (mj-fda-denovo-page-DEN210039.html) and was not used.) Locator: Regulatory information, classification. Retrieved 2026-10-14T18:24:12Z. Source state: Current. Snapshot hash: f1f923890f7894cba63b75965ba5f303404ed1c74db0afa51d93c799aa182af6. How it applies: Classification in the decision summary. 6. Supports: De Novo classification request for SNOO Smart Sleeper (DEN210039), decision summary (Regulator, edition The decision summary PDF, 8 pages, fetched on 2026-10-14. Its text layer prints the device name inconsistently (SNOO in some places and SNO0, with a zero, in others); quotations repeat the text exactly as extracted. The accessdata denovo.cfm page was fetched too (mj-fda-denovo-page-DEN210039.html) and was not used.) Locator: Indications for use, paragraph 1. Retrieved 2026-10-14T18:24:12Z. Source state: Current. Snapshot hash: f1f923890f7894cba63b75965ba5f303404ed1c74db0afa51d93c799aa182af6. How it applies: Intended population and setting, part 1. 7. Supports: De Novo classification request for SNOO Smart Sleeper (DEN210039), decision summary (Regulator, edition The decision summary PDF, 8 pages, fetched on 2026-10-14. Its text layer prints the device name inconsistently (SNOO in some places and SNO0, with a zero, in others); quotations repeat the text exactly as extracted. The accessdata denovo.cfm page was fetched too (mj-fda-denovo-page-DEN210039.html) and was not used.) Locator: Limitations, paragraph 2. Retrieved 2026-10-14T18:24:12Z. Source state: Current. Snapshot hash: f1f923890f7894cba63b75965ba5f303404ed1c74db0afa51d93c799aa182af6. How it applies: Use limited to infants who cannot consistently roll over. 8. Supports: De Novo classification request for SNOO Smart Sleeper (DEN210039), decision summary (Regulator, edition The decision summary PDF, 8 pages, fetched on 2026-10-14. Its text layer prints the device name inconsistently (SNOO in some places and SNO0, with a zero, in others); quotations repeat the text exactly as extracted. The accessdata denovo.cfm page was fetched too (mj-fda-denovo-page-DEN210039.html) and was not used.) Locator: Limitations, paragraph 1. Retrieved 2026-10-14T18:24:12Z. Source state: Current. Snapshot hash: f1f923890f7894cba63b75965ba5f303404ed1c74db0afa51d93c799aa182af6. How it applies: FDA statement that SIDS/SUID reduction was not directly shown. 9. Supports: De Novo classification request for SNOO Smart Sleeper (DEN210039), decision summary (Regulator, edition The decision summary PDF, 8 pages, fetched on 2026-10-14. Its text layer prints the device name inconsistently (SNOO in some places and SNO0, with a zero, in others); quotations repeat the text exactly as extracted. The accessdata denovo.cfm page was fetched too (mj-fda-denovo-page-DEN210039.html) and was not used.) Locator: Labeling, item a. Retrieved 2026-10-14T18:24:12Z. Source state: Current. Snapshot hash: f1f923890f7894cba63b75965ba5f303404ed1c74db0afa51d93c799aa182af6. How it applies: Labeling must carry a warning that a reduction in SIDS or SUID risk has not been shown. 10. Background: De Novo classification request for SNOO Smart Sleeper (DEN210039), decision summary (Regulator, edition The decision summary PDF, 8 pages, fetched on 2026-10-14. Its text layer prints the device name inconsistently (SNOO in some places and SNO0, with a zero, in others); quotations repeat the text exactly as extracted. The accessdata denovo.cfm page was fetched too (mj-fda-denovo-page-DEN210039.html) and was not used.) Locator: Summary of clinical information, paragraph 1. Retrieved 2026-10-14T18:24:12Z. Source state: Current. Snapshot hash: f1f923890f7894cba63b75965ba5f303404ed1c74db0afa51d93c799aa182af6. How it applies: Company real-world evidence on supine position. 11. Background: De Novo classification request for SNOO Smart Sleeper (DEN210039), decision summary (Regulator, edition The decision summary PDF, 8 pages, fetched on 2026-10-14. Its text layer prints the device name inconsistently (SNOO in some places and SNO0, with a zero, in others); quotations repeat the text exactly as extracted. The accessdata denovo.cfm page was fetched too (mj-fda-denovo-page-DEN210039.html) and was not used.) Locator: Postmarket surveillance. Retrieved 2026-10-14T18:24:12Z. Source state: Current. Snapshot hash: f1f923890f7894cba63b75965ba5f303404ed1c74db0afa51d93c799aa182af6. How it applies: Postmarket surveillance requirement. 12. Background: 21 CFR 880.5690 Infant supine sleep system (Regulator, edition eCFR versioner API text for the version dated 2026-10-01, fetched on 2026-10-14. The first two requests (mj-ecfr-880-5690.xml and mj-ecfr-880-5690-b.xml) returned HTTP 406 because they did not accept compression.) Locator: (a) Identification, sentence 1. Retrieved 2026-10-14T18:24:28Z. Source state: Current. Snapshot hash: fd6c5ae46a48c946118abae23b2f4dea2992cb7e75e3959055dedb4a53361cd1. How it applies: The regulation text for the new device type. ## Guidance, authorization and access ### Regulatory decision `maternal:regdec-fda-den210039` - Product: SNOO Smart Sleeper (infant bassinet with supine-position system) (`maternal:snoo-smart-sleeper`) - Authority: U.S. Food and Drug Administration (`core:fda`) - Decision: Granted, 2023-03-30 - Product version: SNOO Smart Sleeper (bassinet with Sleep Sack), De Novo DEN210039 - Pathway: De Novo - Submission: DEN210039 - Product code: QTG - Device class: II - Indication: A bassinet and Sleep Sack jointly intended to facilitate a supine position during sleep, for home use by caregivers of infants from birth to 6 months of age who are not yet able to roll over consistently. FDA states the device has not directly demonstrated a reduction in the incidence of SIDS or SUID. - Jurisdictions: United States; note: United States - Applies to: Recipient: Child; Population: Infants from birth to 6 months of age who are not yet able to roll over consistently, cared for at home by caregivers.; Care setting: Home use by caregivers.; Geography: United States (FDA); Life stage: Newborn and young infant, birth to 6 months of age; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context) - Basis: claim `maternal:claim-fda-den210039-granted` ## Connected pages - De Novo device for infant sleep position: Safe infant sleep (`maternal:safe-infant-sleep`) - Filed under this front: Newborn support: warmth, breathing, feeding (`maternal:front-newborn-support`) ## Provenance Content hash: 999ebe150c473dcb7f19d8981217ef35eefdf4e2789a1b98d3b9bb1b3e535212 Last substantive edit: 2026-10-14 Evidence last checked: 2026-10-14