# K941585: Hygroster

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt Medical
- Decided: Apr 19, 1994 after 19 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.
40 later devices descend from it; 1 cites it directly.
8 of 41 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
- K013089: Ems Hepa Filter and Hme Combinations (2002), 39 descendants of its own
- K033008: Air Safety Hepa and Non-Hepa Filters (2004), 29 descendants of its own
- K060705: Carina Home (2006), 22 descendants of its own
- K103167: Stellar 150 (2011), 20 descendants of its own
- K021265: Datex-Ohmeda Hmef 500 (2002), 11 descendants of its own

Source page: https://510kreport.com/device/K941585
Methodology: https://510kreport.com/methodology