# International Biomedical

- Location (FDA's records): Austin, TX
- FDA decisions: 17 (1996–2022): 17 510(k) clearances
- Names in FDA's records: International Biomedical (8); International Biomedical, Ltd. (6); International Biomedical, Inc. (3)
- Product codes: FPL (7), BTL (2), MRN (2), FPO (1), MPO (1), IMD (1), KGO (1), FMT (1), LBI (1)
- Predicates its devices cite: 19 (5 its own); citations of its devices by later devices: 6 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- International Biomedics, Inc.: 2 (https://510kreport.com/company/international-biomedics)
- CooperSurgical, Inc.: 1 (https://510kreport.com/company/coopersurgical)
- Rapid Aid Corp.: 1 (https://510kreport.com/company/rapid-aid)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)
- Barriermed Glove Co.: 1 (https://510kreport.com/company/barriermed-glove)
- Intl. Biomedics, Inc.: 1 (https://510kreport.com/company/intl-biomedics)
- Wipro GE Healthcare Private, Ltd.: 1 (https://510kreport.com/company/wipro-ge-healthcare-private)
- Draegerwerk AG & CO Kgaa: 1 (https://510kreport.com/company/draegerwerk-ag-co-kgaa)

## Firms that cite its devices most
- Draeger Medical Systems, Inc.: 1 (https://510kreport.com/company/draeger-medical-systems)

## Its most-cited devices
- K103524: Voyager Transport Incubator with Masimo Pulseox, Voyager Transport Incubator with Nellcor Pulseox (2011), cited by 1
- K103527: Aviator Transport Incubator with Masimo Pulseox, Aviator Transport Incubator with Nellcor Pulseox (2011), cited by 1
- K081399: Aviator Transport Incubator (2008), cited by 1
- K022876: Modification to Infant Life Support Module-20 (2002), cited by 1
- K140707: Lifeborne Infant Resuscitator (2014), cited by 1
- K093260: Aeronox Nitric Oxide Titration & Monitoring System (2009), cited by 1

## Recent decisions
- K221154: Infant Heel WarmerTM; Heel Snuggler® (Oct 7, 2022)
- K221653: InfaTherm Disposable Infant Warming Mattress (Oct 6, 2022)
- K220742: NxtGen Infant Transport Incubator (Jul 15, 2022)
- K193481: AeroNOx 2.0 Nitric Oxide Titration & Monitoring System (Mar 10, 2020)
- K182956: Puffin Lite Infant Resuscitation System (Jan 18, 2019)
- K173516: NuBorne Infant Warmer (Aug 17, 2018)
- K160238: Airborne Phototherapy Light (Jun 14, 2016)
- K140707: Lifeborne Infant Resuscitator (May 28, 2014)

Source page: https://510kreport.com/company/international-biomedical