# K153505: F&P Eson 2 Nasal Mask

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare Limited
- Decided: Sep 20, 2016 after 288 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: 9 generations back to K952292 (1995). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121597: Eson Nasal Mask, Fisher & Paykel Healthcare Limited (2012) Summary page 4.

## Indications for use
The F&P Eson™ 2 Nasal Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-level therapy. The F&P Eson™ 2 Nasal Mask is intended for single patient adult (≥ 66lb (30kg)) use in the home and for 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/K153505
Methodology: https://510kreport.com/methodology