# K142554: Revolution Full Face Mask

- Pathway: 510(k) (Abbreviated)
- Applicant: Respironics, Inc.
- Decided: Jan 9, 2015 after 120 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: 3 generations back to K984428 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
2 of 7 devices in its family (counting itself) have 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 4.

## Recalls of this device
- Sep 6, 2022 · Class I · Z-1781-2022: No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.

## Indications for use
This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used on patients (>66lbs/30kg) for whom CPAP and bi-level therapy has been prescribed.

Source page: https://510kreport.com/device/K142554
Methodology: https://510kreport.com/methodology