510(k) · Cleared
ClearedBreathing circuit bacterial/viral filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhejiang Haisheng Medical Device Co., Ltd. · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Dec 18, 2015 as substantially equivalent to K013122 (Engineered Medical Systems, 2002) after a 197-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- Dec 18, 2015
- Review
- 197 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K941381 (1994). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK941381 Hygrobac,S Hygroboy and HygrobabyMallinckrodt Medical · 1994 · Recalled
- 1 generation backK013122 Ems Electrostatic Fliter and Hme CombinationEngineered Medical Systems · 2002
- This deviceK151498 Breathing circuit bacterial/viral filterZhejiang Haisheng Medical Device Co., Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK192713 Altera Filter and HME/FilterMeditera Tibbi Malzeme San VE Tic AS · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK230483 Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter…Passy-Muir, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941381 | Hygrobac,S Hygroboy and Hygrobaby | Mallinckrodt Medical | 1994 | 1 |
| −1 | K013122 | Ems Electrostatic Fliter and Hme Combination | Engineered Medical Systems | 2002 | — |
| 0 (this device) | 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 |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K013122 | Ems Electrostatic Fliter and Hme CombinationSummary page 4…ce(s) [21 CFR 807.92(a)(3)] The identified predicate within this submission is as follows: The EMS Electra Filter and Filter/HME have been cleared by FDA through 510(k) K013122 (Decision Date – April 19, 2002) 510(k) Summary 1‐4 ===… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192713 | Altera Filter and HME/Filter | 2020 | 1 |
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 21 years and passes through 3 companies; a new generation was cleared every 13.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K192713 (Meditera Tibbi Malzeme San VE Tic AS, 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K013122.
How does its category compare?
All CAH devicesCAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is
desired and to add, maintain, retain moisture for the exhaled breathe of the patient. Use up to 24 hours.
The Models of the filters are A501-1, A501-2, A501-3, and A501-4. The filters are intended for patient population that
weighs greater than 10Kgs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151498 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151498: Breathing circuit bacterial/viral filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151498
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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