# K212371: F&P Evora Full Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Mar 18, 2022 after 231 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: 11 generations back to K952292 (1995). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190713: F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large), Fisher & Paykel Healthcare, Ltd. (2019) Summary page 4.

## Indications for use
The F&P Evora Full Face mask is intended to be used by adults weighing > 661bs (30kgs) who have been diagnosed by a physician as requiring CPAP or Bi-Level therapy. The F&P Evora Full Face mask is intended for single patient use in the home and for multiple patient use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

Source page: https://510kreport.com/device/K212371
Methodology: https://510kreport.com/methodology