510(k) · Cleared
ClearedPorous Media DBF23 Disposable Respiratory Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Porous Media Corp. · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Mar 11, 1997 after an 89-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Mar 11, 1997
- Review
- 89 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK964979 Porous Media DBF23 Disposable Respiratory FilterPorous Media Corp. · 1997
- Descendant · cites it directly · 0 of its ownK032716 Portex Thermovent Hepa Hme Breathing Filter with CO2 Port (Sterile…Portex, Ltd. · 2003
- Descendant · cites it directly · 0 of its ownK014281 Gard Filter, Combigard Filte / HmeMunktell Filter AB · 2002
- Descendant · cites it directly · 0 of its ownK982127 Porous Media DEF25 Disposable Respiratory FilterPorous Media Corp. · 1998
Most influential descendants
Showing 3 of 3 · See all- K032716Portex Thermovent Hepa Hme Breathing Filter with CO2 Port (Sterile and Non-Sterile)Portex, Ltd. · 2003 · cites it directly0descendants
- K014281Gard Filter, Combigard Filte / HmeMunktell Filter AB · 2002 · cites it directly0descendants
- K982127Porous Media DEF25 Disposable Respiratory FilterPorous Media Corp. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964979 | Porous Media DBF23 Disposable Respiratory Filter | Porous Media Corp. | 1997 | — |
| +1 | K032716 | Portex Thermovent Hepa Hme Breathing Filter with CO2 Port (Sterile and… | Portex, Ltd. | 2003 | — |
| +1 | K014281 | Gard Filter, Combigard Filte / Hme | Munktell Filter AB | 2002 | — |
| +1 | K982127 | Porous Media DEF25 Disposable Respiratory Filter | Porous Media Corp. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K032716 (Portex, Ltd., 2003) has gone furthest, with 0 descendants of its own.
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 | — |
https://510kreport.com/device/K964979 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964979: Porous Media DBF23 Disposable Respiratory Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964979
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026