# K945938: Respironics Monarch Mini Mask

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Jan 31, 1996 after 422 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
46 later devices descend from it; 3 cite it directly.
7 of 47 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
- K992336: Monarch II Mini Mask (1999), 42 descendants of its own
- K053352: Comfortlite Nasal Mask (2006), 41 descendants of its own
- K082558: Comfortlite Nasal Mask (2009), 36 descendants of its own
- K102746: Mirage FX (2010), 19 descendants of its own
- K123979: Quattro Air (2013), 9 descendants of its own

Source page: https://510kreport.com/device/K945938
Methodology: https://510kreport.com/methodology