Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Passy-Muir, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
298 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230483 | Passy Muir Tracheostomy Viral & Bacterial Airway Protection | Passy-Muir, Inc. | 2023-09-16 | 205 | 0 |
| K990905 | PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 | Passy-Muir, Inc. | 1999-06-11 | 85 | 0 |
| K970365 | PASSY-MUIR O2 ADAPTER; PMA2000 | Passy-Muir, Inc. | 1997-02-12 | 12 | 0 |
| K962714 | PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING | Passy-Muir, Inc. | 1996-10-28 | 108 | 0 |
| K944451 | PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOM | Passy-Muir, Inc. | 1995-07-07 | 298 | 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