# Irvine Biomedical, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 13 (1995–2008): 11 510(k) clearances and 2 original PMA approvals
- Product codes: DRF (11), OAD (1), LPB (1)
- Predicates its devices cite: 6 (6 its own); citations of its devices by later devices: 46 (6 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Innovative Health, LLC: 10 (https://510kreport.com/company/innovative-health)
- Sterilmed, Inc.: 8 (https://510kreport.com/company/sterilmed)
- Stryker Sustainability Solutions: 7 (https://510kreport.com/company/stryker-sustainability-solutions)
- Ascent Healthcare Solutions: 6 (https://510kreport.com/company/ascent-healthcare-solutions)
- St Jude Medical: 3 (https://510kreport.com/company/st-jude-medical)
- Surgical Instrument Service and Savings, Inc.: 2 (https://510kreport.com/company/surgical-instrument-service-and-savings)
- Tz Medical, Inc.: 2 (https://510kreport.com/company/tz-medical)
- Cardionxt, Inc.: 1 (https://510kreport.com/company/cardionxt)

## Its most-cited devices
- K961924: Ibi-1100 Steerable Electrophysiology Catheter System (1997), cited by 12
- K042775: Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology Catheter (2004), cited by 11
- K982232: Modification of the Ibi-1100 Steerable Electrophysiology Catheter System (1998), cited by 6
- K946333: Ibi-1000(TM) Electrophysiology Cathter (1995), cited by 5
- K010471: Afocus Electropysiology Catheter System, Models 81550, 81567, 81568, 81569 (2001), cited by 4
- K060757: Inquiry Optima Plus Steerable Electrophysiology Catheter (2006), cited by 3

## Recent decisions
- K082061: Inquiry H-Curve TV Steerable Diagnostic Catheter (Aug 19, 2008)
- P060019: Ibi Therapy Cool Path Ablation Catheter & Ibi-1500T9 RF (Mar 16, 2007)
- K060757: Inquiry Optima Plus Steerable Electrophysiology Catheter (Apr 19, 2006)
- K053582: Inquiry Afocus II Diagnostic Catheter (Mar 21, 2006)
- P040014: Ibi Therapy Cardiac Ablation System                    Ers/ 1500T RF Generator (Jan 14, 2005)
- K042775: Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology Catheter (Nov 4, 2004)
- K010471: Afocus Electropysiology Catheter System, Models 81550, 81567, 81568, 81569 (Jun 6, 2001)
- K991878: Luma-Cath Steerable EP Catheters (Dec 10, 1999)

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