Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Puritan-Bennett — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021573 | PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATI | Puritan-Bennett | 2002-08-13 | 91 | 0 |
| K943617 | DISPOSABLE MANUAL RESUSCITATOR | Puritan-Bennett | 1994-08-11 | 15 | 0 |
| K935784 | PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTE | Puritan-Bennett | 1994-07-13 | 219 | 0 |
| K942246 | PURITAN-BENNETT NASAL CPAP MASK | Puritan-Bennett | 1994-07-06 | 58 | 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