Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Passy-Muir, Inc. with 5 510(k) clearances. The most recent is a 510(k) clearance dated Sep 16, 2023: Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 16, 2023 | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)K230483 · CAH | 510(k) clearances |
| Jun 11, 1999 | PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JITK990905 · JOH | 510(k) clearances |
| Feb 12, 1997 | PASSY-MUIR O2 ADAPTER; PMA2000K970365 · JOH | 510(k) clearances |
| Oct 28, 1996 | PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000K962714 · JOH | 510(k) clearances |
| Jul 7, 1995 | PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES)K944451 · JOH | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
