Bentley Laboratories, Inc.: FDA filings under this applicant name
FDA lists 55 510(k) clearances under the applicant name “Bentley Laboratories, Inc.” (first 1976, latest 1993), across 24 product codes in 4 review panels. Median 510(k) review time under this name: 42 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 | 10 | 10 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 6 | 6 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 6 | 6 |
| DRS | Transducer, Blood-Pressure, Extravascular | 4 | 4 |
| DXY | Implantable Pacemaker Pulse-Generator | 4 | 4 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 2 | 2 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 2 | 2 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 2 | 2 |
| KRA | Catheter, Continuous Flush | 2 | 2 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 2 | 2 |
Plus 14 more product codes.
Review panels
- Cardiovascular (43)
- Gastroenterology and Urology (8)
- General Hospital (2)
- Dental (1)
Most recent Bentley Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K931967 | HE-30 GOLD | DTR | 1993-07-13 | 83 |
| K913956 | BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30 | DTN | 1992-01-17 | 134 |
| K913692 | VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) | DTN | 1991-11-15 | 88 |
| K903641 | QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q | KDI | 1990-11-09 | 87 |
| K894826 | UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF | DTZ | 1990-02-28 | 212 |
| K874867 | CATR(TM)-H CARDIOTOMY HOLDER | KPI | 1988-02-02 | 67 |
| K874841 | INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER | DTZ | 1988-02-02 | 70 |
| K874618 | BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER | DQR | 1988-01-19 | 71 |
| K823359 | OXYGEN CONSUMPTION MONITOR #OCM-0100 | DRY | 1983-01-05 | 61 |
| K823273 | BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN. | DTZ | 1983-01-05 | 64 |
45 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bentley Laboratories, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Bentley Laboratories, Inc. (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via DXY)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bentley Laboratories, Inc.?
FDA lists 55 510(k) clearances under the applicant name “Bentley Laboratories, Inc.” (first 1976, latest 1993), across 24 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bentley Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bentley Laboratories, Inc. is 42 days.
Which FDA product codes appear under Bentley Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are DTZ (Oxygenator, Cardiopulmonary Bypass, 10); DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line, 6); DTN (Reservoir, Blood, Cardiopulmonary Bypass, 6).
Next steps
- See all 55 Bentley Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DTZ, Bentley Laboratories, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.