# K052087: Breathing Filter Bacterial/Viral, Model AG7178

- Pathway: 510(k) (Traditional)
- Applicant: Ag Industries
- Decided: Dec 14, 2005 after 134 days
- Product code: CAH (Filter, Bacterial, Breathing-Circuit)
- Device class: 2
- Regulation: 21 CFR 868.5260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K792097 (1979). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961914: Bacteria/Viral Filter, Hudson Respiratory Care, Inc. (1996) Summary page 2.

## Most influential descendants
- K061426: Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47 (2006), 2 descendants of its own
- K091363: Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, Bacteria Filter (2010), 1 descendant of its own
- K131626: Exceleron Bacterial Filters (2014), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K052087
Methodology: https://510kreport.com/methodology