Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bourns Medical Systems, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
32 daysmedian FDA review time
77 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K802118 | BEAR 2 ADULT VOL. VENTILATOR | Bourns Medical Systems, Inc. | 1980-10-03 | 29 | 0 |
| K802051 | NEWBOURNS INFANT VENTILATOR | Bourns Medical Systems, Inc. | 1980-10-03 | 39 | 0 |
| K801697 | MODEL BP-200 INFANT PRESSURE VENTILATOR | Bourns Medical Systems, Inc. | 1980-08-07 | 15 | 0 |
| K791186 | MODEL BP-2000 TIME-CYCLED VENTILATOR | Bourns Medical Systems, Inc. | 1979-07-06 | 11 | 0 |
| K790199 | VENTILATOR MODEL BV-300 INFANT | Bourns Medical Systems, Inc. | 1979-04-13 | 77 | 0 |
| K781760 | HUMIDIFIERS, MODEL:LS-420 AND LS-460 | Bourns Medical Systems, Inc. | 1978-12-20 | 65 | 0 |
| K781485 | PATIENT CIRCUIT MANIFOLD | Bourns Medical Systems, Inc. | 1978-10-16 | 49 | 0 |
| K781515 | MODEL LS-80 ADULT VENTILATION MONITOR | Bourns Medical Systems, Inc. | 1978-10-02 | 32 | 0 |
| K781428 | FLEXTUBES:9, 20, 26 | Bourns Medical Systems, Inc. | 1978-09-11 | 21 | 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