510(k) · Cleared
ClearedBreathing Filter Bacterial/Viral, Model AG7178
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ag Industries · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Dec 14, 2005 as substantially equivalent to K961914 (Hudson Respiratory Care, Inc., 1996) after a 134-day review. Its family tree reaches back 2 generations to 1979. 3 later devices descend from it.
- Decided
- Dec 14, 2005
- Review
- 134 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K792097 (1979). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK792097 Dryden Bacteria FilterDryden Corp. · 1979
- 1 generation backK961914 Bacteria/Viral FilterHudson Respiratory Care, Inc. · 1996
- This deviceK052087 Breathing Filter Bacterial/Viral, Model AG7178Ag Industries · 2005
- Descendant · cites it directly · 2 of its ownK061426 Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25…Porous Media Corp. · 2006
- Descendant · 2 generations on · 1 of its ownK091363 Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950…Ag Industries · 2010
- Descendant · 2 generations on · 0 of its ownK131626 Exceleron Bacterial FiltersExceleron Medical · 2014
Most influential descendants
Showing 3 of 3 · See all- K061426Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47Porous Media Corp. · 2006 · cites it directly2descendants
- K091363Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205…Ag Industries · 2010 · 2 generations on1descendant
- K131626Exceleron Bacterial FiltersExceleron Medical · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K792097 | Dryden Bacteria Filter | Dryden Corp. | 1979 | — |
| −1 | K961914 | Bacteria/Viral Filter | Hudson Respiratory Care, Inc. | 1996 | — |
| 0 (this device) | K052087 | Breathing Filter Bacterial/Viral, Model AG7178 | Ag Industries | 2005 | — |
| +1 | K061426 | Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47 | Porous Media Corp. | 2006 | — |
| +2 | K091363 | Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202… | Ag Industries | 2010 | — |
| +2 | K131626 | Exceleron Bacterial Filters | Exceleron Medical | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K961914 | Bacteria/Viral FilterSummary page 2…age 1 Predicate Devices: The predicate device referenced in this submission is: Hudson Respiratory Care, Inc. - Hudson RCI BacteriaNiral Filter- 510(k) # K961914 Safety and Effectiveness: Performance testing has been completed on the AG Industries Breathing Filter BacterialNiral. The diff… | 1996 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061426 | Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47 | 2006 | 2 |
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 26 years and passes through 3 companies; a new generation was cleared every 16.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K061426 (Porous Media Corp., 2006) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K961914.
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?
The AG Industries Breathing Filter BacterialNiral is a single use replacement filter intended for use in mechanical ventilators, anesthesia machines, manual resuscitation devices, and IPPB machines to reduce the passage of particulate that may carry airborne bacteria and/or viruses. When used with mechanical ventilators, IPPB machines and resuscitation devices, the replacement filter may be used in the hospital, home, or transport applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052087 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052087: Breathing Filter Bacterial/Viral, Model AG7178.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052087
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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