Irvine Biomedical, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Irvine Biomedical, Inc.” (first 1995, latest 2008), plus 2 PMA decisions, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 88 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Abbott, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 11 | 11 |
| LPB | Cardiac Ablation Percutaneous Catheter | 1 | 0 |
| OAD | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | 1 | 0 |
Review panels
- Cardiovascular (13)
Most recent Irvine Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082061 | INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER | DRF | 2008-08-19 | 29 |
| K060757 | INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER | DRF | 2006-04-19 | 29 |
| K053582 | INQUIRY AFOCUS II DIAGNOSTIC CATHETER | DRF | 2006-03-21 | 88 |
| K042775 | INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER | DRF | 2004-11-04 | 29 |
| K010471 | AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 | DRF | 2001-06-06 | 106 |
| K991878 | LUMA-CATH STEERABLE EP CATHETERS | DRF | 1999-12-10 | 191 |
| K991025 | LUMA-CATH FIXED CURVE EP CATHETERS | DRF | 1999-10-15 | 200 |
| K990958 | ORTHOGONAL EP CATHETERS | DRF | 1999-06-03 | 73 |
| K982232 | MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM | DRF | 1998-07-25 | 30 |
| K961924 | IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM | DRF | 1997-04-11 | 329 |
1 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P060019 | PMA | IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF | 2007-03-16 |
| P040014 | PMA | IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATOR | 2005-01-14 |
Recalls
openFDA lists no recalls under a recalling firm named Irvine Biomedical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Irvine Scientific Sales Co., Inc. (40 510(k)s)
- Irvine Scientific (16 510(k)s)
- Irvine Diagnostic Services (10 510(k)s)
- Irvine Biomedical,Inc.(Ibi) (1 510(k)s)
- Irvine Biomedical, A St. Jude Medical Company (1 510(k)s)
- Irvine Biomedical, Inc., A St. Jude Medical Company (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Irvine Biomedical, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Irvine Biomedical, Inc.” (first 1995, latest 2008), plus 2 PMA decisions, across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Irvine Biomedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Irvine Biomedical, Inc. is 88 days.
Which FDA product codes appear under Irvine Biomedical, Inc.?
The most frequent FDA product codes under this applicant name are DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording, 11); LPB (Cardiac Ablation Percutaneous Catheter, 1); OAD (Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter, 1).
Next steps
- See all 11 Irvine Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRF, Irvine Biomedical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.