# K163464: Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)

- Pathway: 510(k) (Traditional)
- Applicant: Bmc Medical., Ltd.
- Decided: Sep 5, 2017 after 270 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: 8 generations back to K982530 (1998). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133009: Nasal Mask, Nasal Mask, Full Face Mask, BMC Medical Co., Ltd. (2014) Summary page 4.
- K123979: Quattro Air, Resmed, Ltd. (2013) Summary page 4.

## Indications for use
The Viva Nasal Mask channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system. The Viva Nasal Mask is: To be used by adult patients (>66lbs / >30kg) for whom positive airway pressure has been prescribed. Intended for single-patient reuse. The Numa Full Face Mask channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system. The Numa Full Face Mask is: To be used by adult patients (>66lbs / >30kg) for whom positive airway pressure has been prescribed. Intended for single-patient reuse.

Source page: https://510kreport.com/device/K163464
Methodology: https://510kreport.com/methodology