American Bentley: FDA clearances and approvals
American Bentley has 59 FDA 510(k) clearances (first 1983, latest 1988), across 17 product codes in 4 review panels. Median 510(k) review time: 75 days.
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 |
|---|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | 13 | 13 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 11 | 11 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 7 | 7 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 5 | 5 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 4 | 4 |
| CCE | Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling | 3 | 3 |
| DRS | Transducer, Blood-Pressure, Extravascular | 3 | 3 |
| DTP | Defoamer, Cardiopulmonary Bypass | 2 | 2 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
Plus 7 more product codes.
Review panels
- Cardiovascular (51)
- Anesthesiology (4)
- Gastroenterology and Urology (2)
- General and Plastic Surgery (2)
Most recent American Bentley 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K872896 | UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100 | CCE | 1988-02-12 | 204 |
| K873923 | INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER | DTZ | 1987-11-06 | 42 |
| K872167 | CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500 | DTP | 1987-09-01 | 85 |
| K870804 | CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100 | DTR | 1987-09-01 | 186 |
| K872133 | OXYGENATOR MODEL NO. BENTLEY 5 PLUS | DTZ | 1987-08-24 | 83 |
| K870911 | INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY | CCC | 1987-05-29 | 84 |
| K870269 | ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-100 | GEI | 1987-03-09 | 45 |
| K863249 | OXYGENATOR MODEL NO. BENTLEY-10 PLUS | DTZ | 1986-10-20 | 59 |
| K861641 | HEPARIN-COATED EXTRACORPOREAL CIRCUITS | DTZ | 1986-09-29 | 152 |
| K862549 | ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE | KRI | 1986-07-15 | 12 |
49 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Bentley.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does American Bentley have?
American Bentley has 59 FDA 510(k) clearances (first 1983, latest 1988), across 17 product codes in 4 review panels.
How long does FDA take to clear American Bentley's 510(k)s?
The median time from FDA receipt to decision across American Bentley's cleared 510(k)s is 75 days.
What devices does American Bentley make?
Its most frequent FDA product codes are DTZ (Oxygenator, Cardiopulmonary Bypass, 13); DTN (Reservoir, Blood, Cardiopulmonary Bypass, 11); KRI (Accessory Equipment, Cardiopulmonary Bypass, 7).
Has American Bentley had device recalls?
openFDA lists no recalls under a recalling firm name matching American Bentley. Related entities may recall under other names.
Next steps
- See all 59 American Bentley clearances with predicates and recalls
- Run predicate analysis for product code DTZ, American Bentley's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.