510(k) Report

FDA applicant

International Biomedical

Austin, TX17 decisions1996–20220 recalls

FDA records 17 decisions for International Biomedical (Austin, TX) from 1996 to 2022: 17 510(k) clearances. Most are in product codes FPL (Incubator, Neonatal Transport) and BTL (Ventilator, Emergency, Powered (Resuscitator)). Its devices cite 19 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “International Biomedical, Ltd.”, “International Biomedical, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided International Biomedical’s devices, and how often a recall has named them.

FDA decisions per year

3in 2022

2008: 12009: 12011: 42014: 12016: 12018: 12019: 12020: 12022: 3
2007high 4 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — International Biomedical by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like International Biomedical’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FPLIncubator, Neonatal Transport7decisions
  • BTLVentilator, Emergency, Powered (Resuscitator)2decisions
  • MRNApparatus, Nitric Oxide Delivery2decisions
  • FPOStretcher, Wheeled1decision
  • MPOInfant Heel Warmer (Chemical Heat Pack)1decision
  • IMDPack, Hot Or Cold, Disposable1decision

Also: KGO (1), FMT (1), LBI (1).

Whose devices does it build on?

Its devices cite 19 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K103524Voyager Transport Incubator with Masimo Pulseox, Voyager Transport Incubator with Nellcor PulseoxInternational Biomedical, Ltd. · 20111cites it
  • K103527Aviator Transport Incubator with Masimo Pulseox, Aviator Transport Incubator with Nellcor PulseoxInternational Biomedical, Ltd. · 20111cites it
  • K081399Aviator Transport IncubatorInternational Biomedical, Ltd. · 20081cites it
  • K022876Modification to Infant Life Support Module-20International Biomedical, Inc. · 20021cites it
  • K140707Lifeborne Infant ResuscitatorInternational Biomedical · 20141cites it
  • K093260Aeronox Nitric Oxide Titration & Monitoring SystemInternational Biomedical, Ltd. · 20091cites it

What has FDA decided for it lately?

  • K221154Infant Heel WarmerTM; Heel Snuggler®International Biomedical · 2022
  • K221653InfaTherm Disposable Infant Warming MattressInternational Biomedical · 2022
  • K220742NxtGen Infant Transport IncubatorInternational Biomedical · 2022
  • K193481AeroNOx 2.0 Nitric Oxide Titration & Monitoring SystemInternational Biomedical · 2020
  • K182956Puffin Lite Infant Resuscitation SystemInternational Biomedical · 2019
  • K173516NuBorne Infant WarmerInternational Biomedical · 2018
  • K160238Airborne Phototherapy LightInternational Biomedical · 2016
  • K140707Lifeborne Infant ResuscitatorInternational Biomedical · 2014

All 8 as International Biomedical →All 6 as International Biomedical, Ltd. →All 3 as International Biomedical, Inc. →