# K131626: Exceleron Bacterial Filters

- Pathway: 510(k) (Traditional)
- Applicant: Exceleron Medical
- Decided: Feb 26, 2014 after 267 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: 8 generations back to K933081 (1994). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091363: Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, Bacteria Filter, Ag Industries (2010) Summary page 2.
- K061426: Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47, Porous Media Corp. (2006) Summary page 2.

## Indications for use
Exceleron Medical bacterial filters are single use replacement filters intended for use in oxygen concentrator machines to help remove contaminants, including air borne bacteria and other particulate debris from an air stream. When used with oxygen concentrator machines, the replacement filters may be used in the home, nursing home, hospital, patient care facility.

Source page: https://510kreport.com/device/K131626
Methodology: https://510kreport.com/methodology