# K133009: Nasal Mask, Nasal Mask, Full Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: BMC Medical Co., Ltd.
- Decided: Apr 23, 2014 after 210 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: 6 generations back to K982530 (1998). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092835: Comfortgel Nasal Mask, Respironics Inc., Sleep & Home Respiratory Group (2010) Summary page 1.
- K030798: Mirage Activa Mask, Resmed, Ltd. (2003) Summary page 1.
- K113127: Mirage Quattro, Resmed, Ltd. (2012)

## Most influential descendants
- K163464: Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) (2017), 0 descendants of its own

## Indications for use
The BMC-NM, BMC-NM2 Nasal Mask and BMC-FM full face mask channel airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system. The BMC-NM, BMC-NM2 Nasal Mask and BMC-FM full face mask are: * To be used by adult patients (>661bs / >30kg) for whom positive airway pressure has been prescribed. Intended for single-patient reuse in home environment and multi-patient re-use in the hospital/institutional environment.

Source page: https://510kreport.com/device/K133009
Methodology: https://510kreport.com/methodology