# K082866: Revolutionfull Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Respironics Inc., Sleep & Home Respiratory Group
- Decided: Jan 30, 2009 after 123 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K984428 (1999). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
2 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073600: Comfortgel Full Face Mask, Respironics Inc., Sleep & Home Respiratory Group (2008) Summary page 1.
- K023068: Papillon Mask Set, Map Medizintechnik Fur Arzt Und Patient GmbH (2003) Summary page 1.

## Most influential descendants
- K140580: Revolution Fullface Mask (2015), 0 descendants of its own
- K142554: Revolution Full Face Mask (2015), 0 descendants of its own

## Recalls of this device
- Sep 6, 2022 · Class I · Z-1780-2022: No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.

## Indications for use
The Revolution Full Face Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is intended for single patient reuse in the home and multi-patient, multi-use in the hospitalinstitutional environment. The mask is to be used on patients (>661bs/30kg) for whom CPAP or bi-level therapy has been prescribed.

Source page: https://510kreport.com/device/K082866
Methodology: https://510kreport.com/methodology