# Fisher and Paykel Bubble CPAP System Product · id `maternal:fisher-paykel-bubble-cpap` · 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. Also called: Bubble CPAP System Browse, life stage: Newborn Browse, care area: Preterm and sick newborns ## In plain language A bubble CPAP system for premature and full-term newborns up to 10 kg, cleared by the US FDA in 2010. FDA cleared it for use in hospital, such as a neonatal or paediatric intensive care unit, for babies who breathe on their own and need CPAP that a doctor has prescribed. It is cleared only for that use. ## Technical summary 510(k) K100011, applicant Fisher & Paykel Healthcare Ltd, decision Substantially Equivalent on 2010-10-08, traditional clearance, product code BZD, 21 CFR 868.5905 (noncontinuous ventilator), device class 2. The summary's device description: input gas flows of 4 to 15 L/min and CPAP levels of 3 to 10 cmH2O. The summary lists contraindications (non-spontaneously breathing infants, infants not needing CPAP, gas flows over 15 L/min, non-hospital environments). The 510(k) summary PDF is a scanned image, read by eye. No claim about cost or low-resource use is made: the sources read do not state any. ## Claims, with the population each applies to ## Context: Premature and full-term neonates up to 10 kg who breathe spontaneously and need prescribed CPAP in hospital, US 510(k) clearance of the Fisher and Paykel Bubble CPAP System (K100011) Recipient: Newborn; Population: Spontaneously breathing neonates and infants who need breathing support because of conditions linked to prematurity (such as respiratory distress syndrome) or other conditions where CPAP is required or desired and a physician prescribes it. The intended population is premature and full-term neonates up to 10 kg. The summary lists contraindications: infants who are not breathing spontaneously, infants not needing CPAP support, gas flows over 15 L/min and non-hospital environments.; Care setting: Hospital clinical environment such as a neonatal or paediatric intensive care unit (the Indications for Use form); the summary names the environment of use as hospital.; Geography: United States (FDA clearance); Life stage: Neonatal period, up to a weight of 10 kg; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context) ### FDA cleared the Fisher & Paykel Healthcare Bubble CPAP System from applicant Fisher & Paykel Healthcare, Ltd. under 510(k) K100011, with the decision Substantially Equivalent dated 2010-10-08 (traditional clearance, product code BZD, 21 CFR 868.5905, noncontinuous ventilator, class II). The Indications for Use statement says the system is intended to provide CPAP to spontaneously breathing neonates and infants who need breathing support because of conditions associated with prematurity (such as respiratory distress syndrome) or other conditions where CPAP is required or desired and is prescribed by a physician. It is for use in the hospital clinical environment such as a NICU or PICU, the intended population is premature and full-term neonates up to 10 kg, it is for prescription use, and all components are single use only. The summary lists contraindications: non-spontaneously breathing infants, infants not requiring CPAP support, gas flows over 15 L/min and non-hospital environments. - Category: Regulatory - Evidence stage: Evidence stage not applicable - Certainty: Certainty not assessed - Applies to: Recipient: Newborn; Population: Spontaneously breathing neonates and infants who need breathing support because of conditions linked to prematurity (such as respiratory distress syndrome) or other conditions where CPAP is required or desired and a physician prescribes it. The intended population is premature and full-term neonates up to 10 kg. The summary lists contraindications: infants who are not breathing spontaneously, infants not needing CPAP support, gas flows over 15 L/min and non-hospital environments.; Care setting: Hospital clinical environment such as a neonatal or paediatric intensive care unit (the Indications for Use form); the summary names the environment of use as hospital.; Geography: United States (FDA clearance); Life stage: Neonatal period, up to a weight of 10 kg; 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 baby. The 510(k) summary is a scanned image, read by eye and typed, so the quotations cannot be checked by a text search of the file; the openFDA record is the dataset copy as of its update date. The performance data and the comparison with the predicate (a Dräger ventilator in CPAP mode) were not recorded. - Last checked: 2026-10-15 - Sources: 1. Supports: FDA 510(k) premarket notification K100011: FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval on 2026-10-15 fetched the 510(k) summary PDF, which is a scanned image with no text layer; it was read by eye and every quotation was typed from the page.) Locator: results\[0\].decision\_date, decision\_description and clearance\_type. Retrieved 2026-10-15T13:49:21Z. Source state: Current. Snapshot hash: 6f8d31cec22c740a0226692e262b3d805ab9e84010c6d849691a8d2eb13e65c0. How it applies: openFDA 510(k) JSON, CC0. 2. Supports: FDA 510(k) premarket notification K100011: FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval on 2026-10-15 fetched the 510(k) summary PDF, which is a scanned image with no text layer; it was read by eye and every quotation was typed from the page.) Locator: results\[0\].product\_code, applicant, k\_number and openfda device class and regulation number. Retrieved 2026-10-15T13:49:21Z. Source state: Current. Snapshot hash: 6f8d31cec22c740a0226692e262b3d805ab9e84010c6d849691a8d2eb13e65c0. How it applies: openFDA 510(k) JSON, CC0. 3. Supports: FDA 510(k) premarket notification K100011: FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM (openFDA record) (Regulator, edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval on 2026-10-15 fetched the 510(k) summary PDF, which is a scanned image with no text layer; it was read by eye and every quotation was typed from the page.) Locator: Indications for Use Statement; Summary, Contra-indications; clearance letter. Retrieved 2026-10-15T13:51:38Z. Source state: Current. Snapshot hash: 7f69054ff8e534b63bf8dc36052683ff53c60a47c0fd14feba56c109dabf37a0. How it applies: 510(k) summary PDF released by FDA; short quotation; scanned image typed by hand. ## Guidance, authorization and access ### Regulatory decision `maternal:regdec-fda-k100011` - Product: Fisher and Paykel Bubble CPAP System (`maternal:fisher-paykel-bubble-cpap`) - Authority: U.S. Food and Drug Administration (`core:fda`) - Decision: Clearance, 2010-10-08 - Product version: Fisher & Paykel Healthcare Bubble CPAP System as cleared under K100011 - Pathway: 510(k) - Submission: K100011 - Product code: BZD - Device class: II - Indication: Cleared use, as the Indications for Use statement words it: to provide CPAP to spontaneously breathing neonates and infants who require breathing support due to conditions associated with prematurity (such as Respiratory Distress Syndrome) or other conditions where CPAP is required or desired and is prescribed by a physician; for use in the hospital clinical environment such as the NICU and PICU; intended patient population premature and full term neonates up to a weight of 10 kg; prescription use; all components single use only. Contra-indicated in non-spontaneously breathing infants, infants not requiring CPAP support, gas flows over 15 L/min and in non-hospital environments (510(k) summary). - Jurisdictions: United States; note: United States - Applies to: Recipient: Newborn; Population: Spontaneously breathing neonates and infants who need breathing support because of conditions linked to prematurity (such as respiratory distress syndrome) or other conditions where CPAP is required or desired and a physician prescribes it. The intended population is premature and full-term neonates up to 10 kg. The summary lists contraindications: infants who are not breathing spontaneously, infants not needing CPAP support, gas flows over 15 L/min and non-hospital environments.; Care setting: Hospital clinical environment such as a neonatal or paediatric intensive care unit (the Indications for Use form); the summary names the environment of use as hospital.; Geography: United States (FDA clearance); Life stage: Neonatal period, up to a weight of 10 kg; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context) - Basis: claim `maternal:claim-fda-k100011` ## Connected pages - Bubble CPAP: pressure from a water column: Continuous positive airway pressure (CPAP) for newborns (`maternal:nasal-cpap`) - Filed under this front: Newborn support: warmth, breathing, feeding (`maternal:front-newborn-support`) ## Provenance Content hash: 36306c71d6f95a5becb108c97444014e8236c8850e353e6dc4775436fc333a42 Last substantive edit: 2026-10-15 Evidence last checked: 2026-10-15