Bear Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Bear Medical Systems, Inc.” (first 1982, latest 1999), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 78 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 12 | 12 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 4 | 4 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 4 | 4 |
| BSZ | Gas-Machine, Anesthesia | 2 | 2 |
| BTI | Compressor, Air, Portable | 1 | 1 |
| BYT | Ventilator, External Body, Negative Pressure, Adult (Cuirass) | 1 | 1 |
| CAD | Vaporizer, Anesthesia, Non-Heated | 1 | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 | 1 |
| ESE | Larynx, Artificial (Battery-Powered) | 1 | 1 |
| FLI | Cabinet, Ethylene-Oxide Gas Aerator | 1 | 1 |
Review panels
- Anesthesiology (26)
- Ear, Nose and Throat (1)
- General Hospital (1)
Most recent Bear Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992788 | BEAR CUB 750 PSV | CBK | 1999-09-16 | 28 |
| K983981 | BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE | CBK | 1998-11-20 | 11 |
| K912619 | BEAR 7 VENTILATOR | CBK | 1992-06-11 | 364 |
| K900637 | BEAR CEM CONTROLLER | CBK | 1990-08-03 | 175 |
| K896315 | BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY | BTT | 1990-01-22 | 82 |
| K893034 | VHS 820 HUMIDIFIER, MODIFICATION | BTT | 1989-07-14 | 85 |
| K890724 | MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR | BZK | 1989-03-30 | 45 |
| K882764 | BEAR EVC-100 CONTROLLER | CBK | 1988-09-30 | 86 |
| K881335 | BEAR 3 VENTILATOR | CBK | 1988-08-04 | 128 |
| K872660 | BEAR NVM-1 | BZK | 1988-02-12 | 220 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bear Medical Systems, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Bear Medical Systems, Inc.?
FDA lists 28 510(k) clearances under the applicant name “Bear Medical Systems, Inc.” (first 1982, latest 1999), across 10 product codes in 3 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 Bear Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bear Medical Systems, Inc. is 78 days.
Which FDA product codes appear under Bear Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 12); BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 4); BZK (Spirometer, Monitoring (W/Wo Alarm), 4).
Next steps
- See all 28 Bear Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBK, Bear Medical Systems, 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.