# K121597: Eson Nasal Mask

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare Limited
- Decided: Oct 2, 2012 after 124 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). 28 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 33 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.

## Most influential descendants
- K130328: F&P Simplus Full Face Mask (2013), 2 descendants of its own
- K190713: F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) (2019), 1 descendant of its own
- K212371: F&P Evora Full Face Mask (2022), 0 descendants of its own
- K153505: F&P Eson 2 Nasal Mask (2016), 0 descendants of its own

## Indications for use
The F&P Eson 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 F&P Eson 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/K121597
Methodology: https://510kreport.com/methodology