Data / Medical devices / United States / International Biomedical, Ltd.

International Biomedical, Ltd.: FDA-registered device maker in Austin, TX, United States, 21 510(k) clearances

Name: International Biomedical, Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

International Biomedical, Ltd. is registered with the FDA (registration 1625392) in Austin, TX, United States. It lists 18 device types. The FDA files 21 510(k) clearances under its listings, the newest dated October 7, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1625392
FEI number: 1000058335
Address: 8206 Cross Park Dr, Austin, TX, United States, 78754
Owner or operator: INTERNATIONAL BIOMEDICAL, LTD. (1629497)
Roles: Complaint file establishment, Manufacturer
First device listed: December 3, 1992
Registered through: 2026
Brand names listed: 185A+ with Optional PulseOx Transport Incubator, A750i with Optional PulseOx Transport Incubator, AIRBORNE 750I INFANT, AeroNOx 2 Nitric Oxide Delivery Device, Aeronox, Aeronox Nitric Oxide Delivery System, Airborne Phototherapy Light Bar, Aviator Transport Incubator and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Nitric Oxide	MRP	2	Manufacturer	accessdata.fda.gov
Analyzer, Nitrogen Dioxide	MRQ	2	Manufacturer	accessdata.fda.gov
Apparatus, Nitric Oxide Delivery	MRN	2	Manufacturer	accessdata.fda.gov
Apparatus, Nitric Oxide, Backup Delivery	MRO	2	Manufacturer	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Manufacturer	accessdata.fda.gov
Humidifier, Respiratory Gas, (Direct Patient Interface)	BTT	2	Manufacturer	accessdata.fda.gov
Incubator, Neonatal Transport	FPL	2	Manufacturer	accessdata.fda.gov
Infant Heel Warmer (Chemical Heat Pack)	MPO	1	Manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Manufacturer	accessdata.fda.gov
Pad, Neonatal Eye	FOK	1	Manufacturer	accessdata.fda.gov
Protector, Skin Pressure	FMP	1	Manufacturer	accessdata.fda.gov
Pump, Infusion, Analytical Sampling	LZF	2	Manufacturer	accessdata.fda.gov
Strip, Temperature, Forehead, Liquid Crystal	KPD	2	Manufacturer	accessdata.fda.gov
Transilluminator, Battery-Powered	HJN	1	Manufacturer	accessdata.fda.gov
Unit, Neonatal Phototherapy	LBI	2	Manufacturer	accessdata.fda.gov
Ventilator, Continuous, Facility Use	CBK	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Ventilator, Emergency, Powered (Resuscitator)	BTL	2	Manufacturer	accessdata.fda.gov
Warmer, Infant Radiant	FMT	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 7, 2022	K221154	Infant Heel WarmerTM; Heel Snuggler®	MPO	Substantially Equivalent	International Biomedical	accessdata.fda.gov
October 6, 2022	K221653	InfaTherm Disposable Infant Warming Mattress	IMD	Substantially Equivalent	International Biomedical	accessdata.fda.gov
July 15, 2022	K220742	NxtGen Infant Transport Incubator	FPL	Substantially Equivalent	International Biomedical	accessdata.fda.gov
March 10, 2020	K193481	AeroNOx 2.0 Nitric Oxide Titration & Monitoring System	MRN	Substantially Equivalent	International Biomedical	accessdata.fda.gov
January 18, 2019	K182956	Puffin Lite Infant Resuscitation System	BTL	Substantially Equivalent	International Biomedical	accessdata.fda.gov
August 17, 2018	K173516	NuBorne Infant Warmer	FMT	Substantially Equivalent	International Biomedical	accessdata.fda.gov
June 14, 2016	K160238	Airborne Phototherapy Light	LBI	Substantially Equivalent	International Biomedical	accessdata.fda.gov
May 28, 2014	K140707	LIFEBORNE INFANT RESUSCITATOR	BTL	Substantially Equivalent	International Biomedical	accessdata.fda.gov
May 11, 2011	K103525	A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX	FPL	Substantially Equivalent	International Biomedical, Ltd.	accessdata.fda.gov
May 11, 2011	K103523	185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX	FPL	Substantially Equivalent	International Biomedical, Ltd.	accessdata.fda.gov
April 15, 2011	K103527	AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX	FPL	Substantially Equivalent	International Biomedical, Ltd.	accessdata.fda.gov
April 15, 2011	K103524	VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX	FPL	Substantially Equivalent	International Biomedical, Ltd.	accessdata.fda.gov
December 16, 2009	K093260	AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM	MRN	Substantially Equivalent	International Biomedical, Ltd.	accessdata.fda.gov
June 6, 2008	K081399	AVIATOR TRANSPORT INCUBATOR	FPL	Substantially Equivalent	International Biomedical, Ltd.	accessdata.fda.gov
June 24, 2003	K031096	MODIFICATION TO TRANSPORT INCUBATOR 185	FPL	Substantially Equivalent	International Biomedics, Inc.	accessdata.fda.gov
September 11, 2002	K022876	MODIFICATION TO INFANT LIFE SUPPORT MODULE-20	FPL	Substantially Equivalent	International Biomedical, Inc.	accessdata.fda.gov
August 4, 2000	K000653	AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002	MRN	Substantially Equivalent	Pulmonox Medical Corp.	accessdata.fda.gov
February 28, 1996	K951739	PUMP/BLOOD CHEMISTRY MONITOR	LZF	Substantially Equivalent	Via Medical Corp.	accessdata.fda.gov
January 11, 1994	K922997	VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD.	LZF	Unknown	Via Medical Corp.	accessdata.fda.gov
June 13, 1991	K905234	TXP TRANSPORTER FAMILY AND RELATED ACCESSORIES	CBK	Substantially Equivalent	Percussionaire Corp.	accessdata.fda.gov
April 3, 1987	K870173	LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL	BTT	Substantially Equivalent	Mauna Loa Medical, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 24, 2013	65341	Class II	Terminated	VIA Medical Collection Bag; The collection bag is an accessory waste bag used in conjunction with the sterile LVM blood gas sensor with the LVM Monitor. The collection bag is packaged in a tyvek pouch which is included i	International Biomedical has received reports of interference between the collection bag and the extension set connectors. Evaluation of the affected components indicates that the collection bag connector can become occluded due to an over-tightening of the luer lock by the end user. To alleviate the occurrence of this issue in the fixture, the connector on	accessdata.fda.gov

Compare with other makers

Updated October 7, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.