# K083832: Zest Nasal Mask

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Mar 16, 2009 after 83 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: 7 generations back to K952292 (1995). 27 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080209: Fisher and Paykel Healthcare Zest Nasal Mask, Fisher & Paykel Healthcare, Ltd. (2008) Summary page 1.
- K063036: Opus HC482 Direct Nasal Mask, Fisher & Paykel Healthcare, Ltd. (2006) Summary page 1.

## Most influential descendants
- K120027: Pilairo Nasal Pillows Mask (2012), 7 descendants of its own
- K161412: F&P Brevida™ Nasal Pillows Mask (2017), 6 descendants of its own
- K200089: F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model (2020), 5 descendants of its own
- K121597: Eson Nasal Mask (2012), 4 descendants of its own
- K130328: F&P Simplus Full Face Mask (2013), 2 descendants of its own

## Indications for use
The Zest TM Nasal Mask is intended to be used by individuals who have been diagnosed. by a physician as requiring CPAP or Bi-level ventilator treatment.. The Zest TM Nasal Mask is intended for Single Patient Adult Use in the home and Multiple Patient Adult 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/K083832
Methodology: https://510kreport.com/methodology