# K992336: Monarch II Mini Mask

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: Aug 13, 1999 after 31 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
Longest line of descent: 1 generation back to K945938 (1996). 1 ancestor in all.
42 later devices descend from it; 1 cites it directly.
7 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945938: Respironics Monarch Mini Mask, Respironics, Inc. (1996) Summary page 1.

## Most influential descendants
- 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
- K102502: Golife Nasal Mask (2010), 9 descendants of its own

## Indications for use
The Respironics Monarch II Mini Mask is intended to provide an interface for application of Respironics CPAP or bi-level therapy to patients. For single patient use in the home or hospital/ institutional environment. The mask is to be used on adult patients (>30 kg) for whom CPAP or bi-level therapy has been prescribed using a Respironics CPAP or bi-level system.

Source page: https://510kreport.com/device/K992336
Methodology: https://510kreport.com/methodology