510(k) Report

FDA applicant

Irvine Biomedical, Inc.

Irvine, CA13 decisions1995–20086 recalls

FDA records 13 decisions for Irvine Biomedical, Inc. (Irvine, CA) from 1995 to 2008: 11 510(k) clearances and 2 original PMA approvals. Most are in product codes DRF (Catheter, Electrode Recording, Or Probe…) and OAD (Catheter, Percutaneous, Cardiac Ablation, For…). Its devices cite 6 predicates, 6 of them its own earlier devices. 6 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Irvine Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

2in 2020

2011: 32012: 12020: 2
2007high 3 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Irvine Biomedical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Irvine Biomedical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DRFCatheter, Electrode Recording, Or Probe, Electrode Recording11decisions
  • OADCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter1decision
  • LPBCardiac Ablation Percutaneous Catheter1decision

Who builds on its devices?

Later devices cite its devices 46 times; 6 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K961924Ibi-1100 Steerable Electrophysiology Catheter SystemIrvine Biomedical, Inc. · 199712cite it
  • K042775Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology CatheterIrvine Biomedical, Inc. · 200411cite it
  • K982232Modification of the Ibi-1100 Steerable Electrophysiology Catheter SystemIrvine Biomedical, Inc. · 19986cite it
  • K946333Ibi-1000(TM) Electrophysiology CathterIrvine Biomedical, Inc. · 19955cite it
  • K010471Afocus Electropysiology Catheter System, Models 81550, 81567, 81568, 81569Irvine Biomedical, Inc. · 20014cite it
  • K060757Inquiry Optima Plus Steerable Electrophysiology CatheterIrvine Biomedical, Inc. · 20063cite it

What has FDA decided for it lately?

  • K082061Inquiry H-Curve TV Steerable Diagnostic CatheterIrvine Biomedical, Inc. · 2008
  • P060019Ibi Therapy Cool Path Ablation Catheter & Ibi-1500T9 RFIrvine Biomedical, Inc. · 20071 recall
  • K060757Inquiry Optima Plus Steerable Electrophysiology CatheterIrvine Biomedical, Inc. · 2006
  • K053582Inquiry Afocus II Diagnostic CatheterIrvine Biomedical, Inc. · 2006
  • P040014Ibi Therapy Cardiac Ablation System Ers/ 1500T RF GeneratorIrvine Biomedical, Inc. · 20053 recalls
  • K042775Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology CatheterIrvine Biomedical, Inc. · 2004
  • K010471Afocus Electropysiology Catheter System, Models 81550, 81567, 81568, 81569Irvine Biomedical, Inc. · 2001
  • K991878Luma-Cath Steerable EP CathetersIrvine Biomedical, Inc. · 1999

All 13 as Irvine Biomedical, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K961924Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR…Aug 24, 2020Class II
  • K961924Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICATIONS FOR…Aug 24, 2020Class II
  • P060019The 1500T9 Cardiac Ablation Generator, RO#lBl-89000 is part of the Therapy Cardiac…Jan 5, 2012
  • P0400147 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83725…Feb 10, 2011
  • P0400147 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83726…Feb 10, 2011
  • P0400147 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83724…Feb 10, 2011

Other applicant names beginning “Irvine”

FDA records each applicant name separately; these may or may not be the same firm.

Irvine Scientific Sales Co., Inc. 40Irvine Scientific 16Irvine Diagnostic Services 10Irvine Biomedical,Inc.(Ibi) 2Irvine Biomedical, A St. Jude Medical Company 2