Irvine Biomedical,Inc.(Ibi): FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Irvine Biomedical,Inc.(Ibi)” (first 2007, latest 2007), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 76 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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| OAD | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | 1 | 0 |
Review panels
- Cardiovascular (2)
Most recent Irvine Biomedical,Inc.(Ibi) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K070011 | IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER | DQO | 2007-03-20 | 76 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P040042 | PMA | THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER | 2005-11-18 |
Recalls
openFDA lists no recalls under a recalling firm named Irvine Biomedical,Inc.(Ibi).
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 Biomedical, Inc. (11 510(k)s)
- Irvine Diagnostic Services (10 510(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.(Ibi)?
FDA lists 1 510(k) clearance under the applicant name “Irvine Biomedical,Inc.(Ibi)” (first 2007, latest 2007), plus 1 PMA decision, across 2 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.(Ibi)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Irvine Biomedical,Inc.(Ibi) is 76 days.
Which FDA product codes appear under Irvine Biomedical,Inc.(Ibi)?
The most frequent FDA product codes under this applicant name are DQO (Catheter, Intravascular, Diagnostic, 1); OAD (Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter, 1).
Next steps
- See all 1 Irvine Biomedical,Inc.(Ibi) clearances with predicates and recalls
- Run predicate analysis for product code DQO, Irvine Biomedical,Inc.(Ibi)'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.