Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bear Medical Systems, Inc. · Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
82 daysmedian FDA review time
196 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992788 | BEAR CUB 750 PSV | Bear Medical Systems, Inc. | 1999-09-16 | 28 | 0 |
| K983981 | BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICOR | Bear Medical Systems, Inc. | 1998-11-20 | 11 | 0 |
| K912619 | BEAR 7 VENTILATOR | Bear Medical Systems, Inc. | 1992-06-11 | 364 | 0 |
| K900637 | BEAR CEM CONTROLLER | Bear Medical Systems, Inc. | 1990-08-03 | 175 | 0 |
| K896315 | BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY | Bear Medical Systems, Inc. | 1990-01-22 | 82 | 0 |
| K893034 | VHS 820 HUMIDIFIER, MODIFICATION | Bear Medical Systems, Inc. | 1989-07-14 | 85 | 0 |
| K890724 | MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR | Bear Medical Systems, Inc. | 1989-03-30 | 45 | 0 |
| K882764 | BEAR EVC-100 CONTROLLER | Bear Medical Systems, Inc. | 1988-09-30 | 86 | 0 |
| K881335 | BEAR 3 VENTILATOR | Bear Medical Systems, Inc. | 1988-08-04 | 128 | 0 |
| K872660 | BEAR NVM-1 | Bear Medical Systems, Inc. | 1988-02-12 | 220 | 0 |
| K873634 | BEAR VH-820 HUMIDIFIER | Bear Medical Systems, Inc. | 1987-12-02 | 84 | 0 |
| K871985 | BEAR JET VENTILATOR FOR USE DURING (ESWL) | Bear Medical Systems, Inc. | 1987-06-15 | 24 | 0 |
| K864589 | TRI-SERVICE OMV VAPORIZER | Bear Medical Systems, Inc. | 1987-06-05 | 196 | 0 |
| K864590 | AM1000 | Bear Medical Systems, Inc. | 1987-05-04 | 164 | 0 |
| K864588 | PENLON CIRCLE SYSTEM | Bear Medical Systems, Inc. | 1987-02-03 | 74 | 0 |
| K864605 | VAPLOK | Bear Medical Systems, Inc. | 1987-02-03 | 71 | 0 |
| K860692 | PTR MK II VENTILATOR | Bear Medical Systems, Inc. | 1986-05-21 | 85 | 0 |
| K853346 | BEAR NICU-1 | Bear Medical Systems, Inc. | 1985-09-11 | 30 | 0 |
| K850795 | AIR COMPRESSOR | Bear Medical Systems, Inc. | 1985-05-28 | 110 | 0 |
| K842688 | BEAR JET-150 VENTILATOR | Bear Medical Systems, Inc. | 1984-07-26 | 16 | 0 |
| K842340 | VH820 HUMIDIFIER | Bear Medical Systems, Inc. | 1984-07-17 | 33 | 0 |
| K842362 | PENLON TRANSPORT VENTILATOR SERIES 350 | Bear Medical Systems, Inc. | 1984-06-26 | 11 | 0 |
| K842363 | PENLON ANESTHESIA VENTILATOR SERIES 300 | Bear Medical Systems, Inc. | 1984-06-26 | 11 | 0 |
| K841279 | BEAR 33 | Bear Medical Systems, Inc. | 1984-05-23 | 56 | 0 |
| K840119 | CONTINUOUS VENTILATOR | Bear Medical Systems, Inc. | 1984-04-06 | 86 | 0 |
| K834555 | BEAR VENTI--VOICE | Bear Medical Systems, Inc. | 1984-01-24 | 28 | 0 |
| K830165 | BEAR JET 150 VENTILATOR | Bear Medical Systems, Inc. | 1983-04-12 | 84 | 0 |
| K822912 | BEAR VM-90 VENTILATION MONITOR | Bear Medical Systems, Inc. | 1982-11-16 | 46 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda