# Biomedical Devices, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 7 (1983–1995): 7 510(k) clearances
- Product codes: FXY (2), FRN (1), GBX (1), BZR (1), LZN (1), LXH (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Tenacore Holdings, Inc.: 1 (https://510kreport.com/company/tenacore-holdings)
- Atom Medical Corporation: 1 (https://510kreport.com/company/atom-medical)
- Precision Medical, Inc.: 1 (https://510kreport.com/company/precision-medical)

## Its most-cited devices
- K925982: BMD Air/Oxygen Blender (1993), cited by 3

## Recent decisions
- K955439: The Reel Thing (Modification) (Dec 26, 1995)
- K931847: Bio-Prep Cement Restrictor (Jun 28, 1994)
- K931846: Bio-Prep (Jan 21, 1994)
- K925982: BMD Air/Oxygen Blender (Oct 7, 1993)
- K903533: Steri-Shield (Oct 19, 1990)
- K902677: Steri-Shield (Aug 17, 1990)
- K830605: Pump Pall Ambulatory Insulin Infusion (Mar 31, 1983)

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