{
  "release_id": "c7fb95f1d15a7d13",
  "id": "maternal:fisher-paykel-bubble-cpap",
  "owner": "maternal",
  "kind": "product",
  "slug": "fisher-paykel-bubble-cpap",
  "name": "Fisher and Paykel Bubble CPAP System",
  "aliases": [
    "Bubble CPAP System"
  ],
  "atlases": [
    "maternal"
  ],
  "summary_plain": "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.",
  "summary_technical": "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.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-15",
  "last_evidence_check": "2026-10-15",
  "next_review_due": null,
  "identifiers": [
    {
      "scheme": "fda-product-code",
      "value": "BZD",
      "normalized_value": "BZD",
      "match": "broad",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "maternal": {
      "life-stage": [
        "newborn"
      ],
      "care-area": [
        "preterm-and-sick-newborn"
      ]
    }
  },
  "payload": {
    "subtype": "device",
    "model_or_formulation": "Fisher & Paykel Healthcare Bubble CPAP System, as named in the openFDA 510(k) record (K100011)",
    "version": "As cleared under K100011 on 2010-10-08",
    "intended_use_snapshots": [
      "maternal:openfda-510k-k100011-2026-10-15",
      "maternal:fda-510k-summary-k100011-2026-10-15"
    ]
  },
  "content_digest": "36306c71d6f95a5becb108c97444014e8236c8850e353e6dc4775436fc333a42",
  "review": {
    "content_digest": "36306c71d6f95a5becb108c97444014e8236c8850e353e6dc4775436fc333a42",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [
    {
      "release_id": "c7fb95f1d15a7d13",
      "id": "maternal:claim-fda-k100011",
      "owner": "maternal",
      "subject_entity_id": "maternal:fisher-paykel-bubble-cpap",
      "category": "regulatory",
      "statement": "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.",
      "context": {
        "id": "maternal:ctx-fda-k100011-us",
        "label": "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_note": "Neonatal period, up to a weight of 10 kg",
        "life_stage_terms": {
          "maternal": [
            "newborn"
          ]
        },
        "gestational_age_min_days": null,
        "gestational_age_max_days": null,
        "gestational_age_basis": null,
        "postnatal_age_min_days": null,
        "postnatal_age_max_days": null,
        "gestational_age_status": null,
        "postnatal_age_status": null,
        "followup_description": "Not applicable (regulatory context)",
        "eligibility": {
          "inclusion": [
            "Spontaneously breathing premature or full-term neonates up to 10 kg who need CPAP, prescribed by a physician"
          ],
          "exclusion": [
            "Infants who are not breathing spontaneously or do not need CPAP support",
            "Gas flows over 15 L/min",
            "Non-hospital environments"
          ]
        }
      },
      "evidence_stage": "not_applicable",
      "certainty": "not_assessed",
      "certainty_method": null,
      "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.",
      "editorial_state": "draft",
      "checked_at": "2026-10-15",
      "next_review_due": null,
      "valid_from": null,
      "valid_to": null,
      "citations": [
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          "applicability_note": "openFDA 510(k) JSON, CC0.",
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            "source_effective_date": "2026-10-05",
            "public_archive_url": null,
            "source_state": "current"
          },
          "source": {
            "id": "maternal:openfda-k100011",
            "source_type": "regulator",
            "title": "FDA 510(k) premarket notification K100011: FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM (openFDA record)",
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            "publisher": "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.",
            "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.",
            "public_text": "quote"
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          "evidence_role": "supports",
          "locator": "results[0].product_code, applicant, k_number and openfda device class and regulation number",
          "applicability_note": "openFDA 510(k) JSON, CC0.",
          "snapshot": {
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            "source_effective_date": "2026-10-05",
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            "source_state": "current"
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          "source": {
            "id": "maternal:openfda-k100011",
            "source_type": "regulator",
            "title": "FDA 510(k) premarket notification K100011: FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM (openFDA record)",
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            "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.",
            "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.",
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            "publisher": "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.",
            "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.",
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      "api_path": "api/v1/claims/maternal--claim-fda-k100011.json"
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  ],
  "decisions": [
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      "type": "regulatory_decision",
      "id": "maternal:regdec-fda-k100011",
      "product_id": "maternal:fisher-paykel-bubble-cpap",
      "product_version": "Fisher & Paykel Healthcare Bubble CPAP System as cleared under K100011",
      "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).",
      "context_id": "maternal:ctx-fda-k100011-us",
      "jurisdictions": [
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  "milestones": [],
  "relationships": {
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        "label": "Bubble CPAP: pressure from a water column",
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