# K063125: Filterflo Hepa; Thermoflo Hepa (Filter / Hme)

- Pathway: 510(k) (Traditional)
- Applicant: Arc Medical, Inc.
- Decided: Apr 13, 2007 after 182 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
No predicates in its family tree.
5 later devices descend from it; 3 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K120079: Primed Tracheostomy Tubes (Multiple) (2012), 2 descendants of its own
- K123699: Fahl Tracheostomy Tubes (Multiple) (2013), 1 descendant of its own
- K233713: Pilling Tracheostomy Tubes (2024), 0 descendants of its own
- K093426: Bact-Trap Hepa Midi (2010), 0 descendants of its own
- K083702: Trach-Assist (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K063125
Methodology: https://510kreport.com/methodology