# K945359: Aqua+I-F, I-H, I-FH, II-H, II-FH, Iii-H

- Pathway: 510(k) (Traditional)
- Applicant: Artema Medical AB
- Decided: Feb 21, 1995 after 111 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.
5 later devices descend from it; 1 cites it directly.
2 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K014282: Bacstop Filter,Bacstop Filter/Hme (2002), 4 descendants of its own
- K072002: Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55 (2008), 3 descendants of its own
- K132709: VR Medical Heat and Moisture Exchanger and Filter (2014), 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

Source page: https://510kreport.com/device/K945359
Methodology: https://510kreport.com/methodology