# K103786: Zest Petite Nasal Mask

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Mar 24, 2011 after 87 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 K952292 (1995). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083832: Zest Nasal Mask, Fisher & Paykel Healthcare, Ltd. (2009) Summary page 1.
- K092835: Comfortgel Nasal Mask, Respironics Inc., Sleep & Home Respiratory Group (2010) Summary page 1.
- K061236: Flexifit HC432 Full Face Mask, Fisher & Paykel Healthcare, Ltd. (2006) Summary page 1.

## Indications for use
The Zest TM Petite Nasal Mask is intended to be used by individuals greater than 661bs (30kg) who have been diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The ZestrTM Petite Nasal Mask is intended for Single Patient Use in the home and 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/K103786
Methodology: https://510kreport.com/methodology