510(k) · Cleared
ClearedAir Safety Model 3000/06 Filter Hepa Reusable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Air Safety, Ltd. · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Jun 29, 2005 as substantially equivalent to K033008 (Air Safety, Ltd., 2004) and 1 other predicate after a 75-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Jun 29, 2005
- Review
- 75 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K941381 (1994). 11 ancestors in all, the oldest K890362 (1989). No later device cites it as a predicate yet.
- Root · 3 generations backK941381 Hygrobac,S Hygroboy and HygrobabyMallinckrodt Medical · 1994 · Recalled
- 2 generations backK013089 Ems Hepa Filter and Hme CombinationsEngineered Medical Systems · 2002
- 1 generation backK033008 Air Safety Hepa and Non-Hepa FiltersAir Safety, Ltd. · 2004
- This deviceK050953 Air Safety Model 3000/06 Filter Hepa ReusableAir Safety, Ltd. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941381 | Hygrobac,S Hygroboy and Hygrobaby | Mallinckrodt Medical | 1994 | 1 |
| −2 | K013089 | Ems Hepa Filter and Hme Combinations | Engineered Medical Systems | 2002 | — |
| −1 | K033008 | Air Safety Hepa and Non-Hepa Filters | Air Safety, Ltd. | 2004 | — |
| 0 (this device) | K050953 | Air Safety Model 3000/06 Filter Hepa Reusable | Air Safety, Ltd. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1994 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 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? (2)
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 |
|---|---|---|---|
| * | K033008 | Air Safety Hepa and Non-Hepa FiltersSummary page 1…ial / Viral Filters Classification Name: Filter, Bacterial, Breathing Circuit, CAH Predicate Devices: Air Safety- Model 3000/04 - K033008 PB Omniflow Filter - K890362 IDevice Description] The Air Safety Model 3000/06 HEPA filt… | 2004 |
| * | K890362 | Omnifilter Main Flow Bacteria FilterSummary page 1…Bacterial, Breathing Circuit, CAH Predicate Devices: Air Safety- Model 3000/04 - K033008 PB Omniflow Filter - K890362 IDevice Description] The Air Safety Model 3000/06 HEPA filter is a multi-use, reusable ventilator in-line filter which connects… | 1989 |
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 11 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 11 ancestors have a recall of any class.
- 3 other devices also cite its predicate K033008.
How does its category compare?
All CAH devicesCAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Filtration of exhaled gases in the ventilator circuit.
Model 3000/06 to be placed in the exhalation pathway of the ventilator circuit where filtration of the expired gases is desired. Filter is reusable up to 100 times, extended use as determined by the increase in airflow resistance, which is determined during self testing (SST) mode of the ventilator. For use with the Series 700 and 7200 NPB ventilators.
Cleaning method - autoclaved - 30 minutes with 3 minutes at 134°C.
Environment of Use -- Hospital, Sub-acute Institutions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050953: Air Safety Model 3000/06 Filter Hepa Reusable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050953
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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