510(k) · Cleared
ClearedGard Filter, Combigard Filte / Hme
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Munktell Filter AB · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Jun 26, 2002 as substantially equivalent to K941676 (Mallinckrodt Medical, 1994) and 2 other predicates after a 181-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jun 26, 2002
- Review
- 181 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K941676 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK941676 Sterivent and Sterivent SMallinckrodt Medical · 1994 · Recalled
- This deviceK014281 Gard Filter, Combigard Filte / HmeMunktell Filter AB · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941676 | Sterivent and Sterivent S | Mallinckrodt Medical | 1994 | 1 |
| 0 (this device) | K014281 | Gard Filter, Combigard Filte / Hme | Munktell Filter AB | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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? (3)
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 |
|---|---|---|---|
| * | K941676 | Sterivent and Sterivent SSummary page 1…Bacterial / Viral Filter Classification Name: Filter, Bacterial, Breathing Circuit Predicate Devices: Mallinckrodt Sterivent (HEPA) - K94 1676 ARC Filter - KO1 1212 Porous Media - DBF 23 - K964979 I… | 1994 |
| * | K011212 | Filterflo H | 2001 |
| * | K964979 | Porous Media DBF23 Disposable Respiratory FilterSummary page 1…Mallinckrodt Sterivent (HEPA) - K94 1676 ARC Filter - KO1 1212 Porous Media - DBF 23 - K964979 IDevice Description: I The Munktell Gard Filter… | 1997 |
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?
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K941676.
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?
For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired and / or expired gases is desired. To be placed at the machine-side of the circuit only.
Single patient use. Duration of use up to 24 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K014281 · printed Nov 3, 2026
Cite this page
510(k) Report. “K014281: Gard Filter, Combigard Filte / Hme.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014281
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026