# K140580: Revolution Fullface Mask

- Pathway: 510(k) (Traditional)
- Applicant: Respironics Inc. (Dba Philips Respironics)
- Decided: Jan 16, 2015 after 316 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: 3 generations back to K984428 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082866: Revolutionfull Face Mask, Respironics Inc., Sleep & Home Respiratory Group (2009) Summary page 5.
- K073600: Comfortgel Full Face Mask, Respironics Inc., Sleep & Home Respiratory Group (2008) Summary page 5.

## Indications for use
The Revolution Full Face Mask is intended to provide an interface for continuous positive airway pressure (CPAP) or bi-level therapy. The mask is intended for single-patient reuse in the home or hospital/institutional environment. The mask is to be used by patients greater than 66lbs/30kg.

Source page: https://510kreport.com/device/K140580
Methodology: https://510kreport.com/methodology