Fisher and Paykel Bubble CPAP System

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)

• Regulatory Evidence stage not applicable Certainty not assessed

  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.

  Applies to Newborn

  • 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.
  • 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.
  • United States (FDA clearance)
  • Neonatal period, up to a weight of 10 kg
  • Gestational age Not reported
  • Postnatal age Not reported

  Follow-up Not applicable (regulatory context)

  Certainty method

  Not assessed

  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

  Next evidence check due

  Not scheduled

  Sources and citations (3)

  1. Supports FDA 510(k) premarket notification K100011: FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM (openFDA record)

     Regulator · U.S. Food and Drug Administration (openFDA) · 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. · 510(k): K100011

     Locator

     results[0].decision_date, decision_description and clearance_type

     How it applies

     openFDA 510(k) JSON, CC0.

     Retrieved

     2026-10-15T13:49:21Z

     Source effective date

     2026-10-05

     Source state

     Current

     Snapshot hash

     6f8d31cec22c740a0226692e262b3d805ab9e84010c6d849691a8d2eb13e65c0

     Reuse basis

     openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the licence page was fetched as mn-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mn-openfda-510k-k100011.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf10/K100011.pdf, fetched as mn-fda-510k-summary-k100011.pdf) is hash only; it is a scanned submission summary released by FDA, and the FDA website policies page (mn-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.

  2. Supports FDA 510(k) premarket notification K100011: FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM (openFDA record)

     Regulator · U.S. Food and Drug Administration (openFDA) · 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. · 510(k): K100011

     Locator

     results[0].product_code, applicant, k_number and openfda device class and regulation number

     How it applies

     openFDA 510(k) JSON, CC0.

     Retrieved

     2026-10-15T13:49:21Z

     Source effective date

     2026-10-05

     Source state

     Current

     Snapshot hash

     6f8d31cec22c740a0226692e262b3d805ab9e84010c6d849691a8d2eb13e65c0

     Reuse basis

     openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the licence page was fetched as mn-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mn-openfda-510k-k100011.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf10/K100011.pdf, fetched as mn-fda-510k-summary-k100011.pdf) is hash only; it is a scanned submission summary released by FDA, and the FDA website policies page (mn-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.

  3. Supports FDA 510(k) premarket notification K100011: FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM (openFDA record)

     Regulator · U.S. Food and Drug Administration (openFDA) · 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. · 510(k): K100011

     Locator

     Indications for Use Statement; Summary, Contra-indications; clearance letter

     How it applies

     510(k) summary PDF released by FDA; short quotation; scanned image typed by hand.

     Retrieved

     2026-10-15T13:51:38Z

     Source effective date

     2010-10-08

     Source state

     Current

     Snapshot hash

     7f69054ff8e534b63bf8dc36052683ff53c60a47c0fd14feba56c109dabf37a0

     Reuse basis

     openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the licence page was fetched as mn-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mn-openfda-510k-k100011.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf10/K100011.pdf, fetched as mn-fda-510k-summary-k100011.pdf) is hash only; it is a scanned submission summary released by FDA, and the FDA website policies page (mn-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.