510(k) · Cleared
ClearedPassy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Passy-Muir, Inc. · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Sep 16, 2023 as substantially equivalent to K192713 (Meditera Tibbi Malzeme San VE Tic AS, 2020) after a 205-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Sep 16, 2023
- Review
- 205 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K941381 (1994). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK941381 Hygrobac,S Hygroboy and HygrobabyMallinckrodt Medical · 1994 · Recalled
- 3 generations backK013122 Ems Electrostatic Fliter and Hme CombinationEngineered Medical Systems · 2002
- 2 generations backK151498 Breathing circuit bacterial/viral filterZhejiang Haisheng Medical Device Co., Ltd. · 2015
- 1 generation backK192713 Altera Filter and HME/FilterMeditera Tibbi Malzeme San VE Tic AS · 2020 · Recalled
- This deviceK230483 Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter…Passy-Muir, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941381 | Hygrobac,S Hygroboy and Hygrobaby | Mallinckrodt Medical | 1994 | 1 |
| −3 | K013122 | Ems Electrostatic Fliter and Hme Combination | Engineered Medical Systems | 2002 | — |
| −2 | K151498 | Breathing circuit bacterial/viral filter | Zhejiang Haisheng Medical Device Co., Ltd. | 2015 | — |
| −1 | K192713 | Altera Filter and HME/Filter | Meditera Tibbi Malzeme San VE Tic AS | 2020 | 1 |
| 0 (this device) | K230483 | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) | Passy-Muir, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CAH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CAH device
- #1 K251583 Ambu® Virobac II® Exhalation Filterscore 11.6 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K192713 | Altera Filter and HME/FilterSummary page 4…et Review: Surgical and Infection Control Devices (OHT4) Infection Control and Plastic Surgery Devices (DHT4B) PREDICATE DEVICE: Altera Filter - K192713 (Filter Only) by Meditera Tibbi Malzeme, San. ve Tic. A.S. DEVICE DESCRIPTION: The Passy Muir Tracheostomy Vir… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 8.0 years on median.
- 3 of the 6 ancestors have a recall of any class.
How does its category compare?
All CAH devicesCAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · CAH
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CAH
237in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAH
1in 2025
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · CAH
77in 2025
MAUDE reports naming product code CAH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 32 |
| 2008 | 1 | — | 0 | 27 |
| 2009 | 4 | 111 | 0 | 18 |
| 2010 | 5 | 216 | 2 | 40 |
| 2011 | 3 | 281 | 0 | 9 |
| 2012 | 3 | 212 | 0 | 16 |
| 2013 | 1 | — | 1 | 47 |
| 2014 | 4 | 250 | 1 | 98 |
| 2015 | 2 | — | 0 | 51 |
| 2016 | 0 | — | 0 | 34 |
| 2017 | 1 | — | 1 | 29 |
| 2018 | 0 | — | 0 | 33 |
| 2019 | 2 | — | 0 | 30 |
| 2020 | 2 | — | 0 | 33 |
| 2021 | 2 | — | 0 | 56 |
| 2022 | 3 | 204 | 6 (6) | 67 |
| 2023 | 3 | 237 | 0 | 40 |
| 2024 | 2 | — | 0 | 51 |
| 2025 | 0 | — | 1 (1) | 77 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
For non-mechanically ventilated tracheostomy patients who are awake and alert or monitored by a trained healthcare provider or caregiver, where filtration of inspired and/or expired gases is desired. Use up to 24 hours.
Environment of use – clinical settings including hospital, sub-acute, pre-hospital, and home. For adults with Tidal Volumes >300 ml and pediatrics with Tidal Volumes >80 ml. Do not use on neonate or infant patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230483 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230483: Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230483
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026