# K903058: Bact-Hme (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Pharma Systems, Inc.
- Decided: Nov 9, 1990 after 121 days
- Product code: BYD (Condenser, Heat And Moisture (Artificial Nose))
- Device class: 1
- Regulation: 21 CFR 868.5375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
1 of 5 devices in its family (counting itself) has 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
- K202459: Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter (2021), 1 descendant of its own
- K221836: Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus (2022), 0 descendants of its own
- K090738: Thermoflo HCH, Thermoflo Filter (2009), 0 descendants of its own
- K982239: Circuit Guard (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K903058
Methodology: https://510kreport.com/methodology