International Biomedical, Ltd.
Austin, TX, US
INTERNATIONAL BIOMEDICAL, LTD. appears in FDA device records in Austin, TX. FDA records list 17 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for International Biomedical, Ltd. between 1996 and 2022. The busiest year on record is 2011, with 4. The most recent is 2022, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2011 | 4 |
| 2014 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K221154 | Infant Heel WarmerTM; Heel Snuggler® | MPO | Substantially Equivalent | |
| K221653 | InfaTherm Disposable Infant Warming Mattress | IMD | Substantially Equivalent | |
| K220742 | NxtGen Infant Transport Incubator | FPL | Substantially Equivalent | |
| K193481 | AeroNOx 2.0 Nitric Oxide Titration & Monitoring System | MRN | Substantially Equivalent | |
| K182956 | Puffin Lite Infant Resuscitation System | BTL | Substantially Equivalent | |
| K173516 | NuBorne Infant Warmer | FMT | Substantially Equivalent | |
| K160238 | Airborne Phototherapy Light | LBI | Substantially Equivalent | |
| K140707 | LIFEBORNE INFANT RESUSCITATOR | BTL | Substantially Equivalent | |
| K103525 | A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX | FPL | Substantially Equivalent | |
| K103523 | 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | FPL | Substantially Equivalent | |
| K103527 | AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | FPL | Substantially Equivalent | |
| K103524 | VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | FPL | Substantially Equivalent | |
| K093260 | AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM | MRN | Substantially Equivalent | |
| K081399 | AVIATOR TRANSPORT INCUBATOR | FPL | Substantially Equivalent | |
| K022873 | POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK) | KGO | Substantially Equivalent | |
| K022876 | MODIFICATION TO INFANT LIFE SUPPORT MODULE-20 | FPL | Substantially Equivalent | |
| K955766 | ADULT-PEDIATRIC TRANSPORT SYSTEM | FPO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1625392 | 1000058335 | INTERNATIONAL BIOMEDICAL, LTD. | 8206 Cross Park Dr, AUSTIN, TX 78754 US | 2026 | and 8 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MRPAnalyzer, Nitric Oxide
- MRQAnalyzer, Nitrogen Dioxide
- MRNApparatus, Nitric Oxide Delivery
- MROApparatus, Nitric Oxide, Backup Delivery
- DRXElectrode, Electrocardiograph
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- FPLIncubator, Neonatal Transport
- MPOInfant Heel Warmer (Chemical Heat Pack)
- IMDPack, Hot Or Cold, Disposable
- FOKPad, Neonatal Eye
- FMPProtector, Skin Pressure
- LZFPump, Infusion, Analytical Sampling
- FPOStretcher, Wheeled
- KPDStrip, Temperature, Forehead, Liquid Crystal
- KGOSurgeon'S Gloves
- HJNTransilluminator, Battery-Powered
- LBIUnit, Neonatal Phototherapy
- CBKVentilator, Continuous, Facility Use
- BTLVentilator, Emergency, Powered (Resuscitator)
- FMTWarmer, Infant Radiant
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1531-2013 | 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 in either replacement kit (777-3103) or LVM sensor kit (777-3102). | 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 the collection bag has been improved to | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain