Passy-Muir, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Passy-Muir, Inc.” (first 1995, latest 2023), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 108 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 205 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Passy-Muir, Inc. took a median 205 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 237 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JOH | Tube Tracheostomy And Tube Cuff | 4 | 4 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
Review panels
- Anesthesiology (4)
- General Hospital (1)
Most recent Passy-Muir, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230483 | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) | CAH | 2023-09-16 | 205 |
| K990905 | PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT | JOH | 1999-06-11 | 85 |
| K970365 | PASSY-MUIR O2 ADAPTER; PMA2000 | JOH | 1997-02-12 | 12 |
| K962714 | PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000 | JOH | 1996-10-28 | 108 |
| K944451 | PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES) | JOH | 1995-07-07 | 298 |
Recalls
openFDA lists no recalls under a recalling firm named Passy-Muir, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Passy & Passy, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Passy-Muir, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Passy-Muir, Inc.” (first 1995, latest 2023), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Passy-Muir, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Passy-Muir, Inc. is 108 days.
Which FDA product codes appear under Passy-Muir, Inc.?
The most frequent FDA product codes under this applicant name are JOH (Tube Tracheostomy And Tube Cuff, 4); CAH (Filter, Bacterial, Breathing-Circuit, 1).
Next steps
- See all 5 Passy-Muir, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JOH, Passy-Muir, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.