# K094040: F&P Icon Series Cpap

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Apr 27, 2010 after 118 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K952292 (1995). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081029: Sleepstyle 200 Auto Series HC254, Fisher & Paykel Healthcare, Ltd. (2008) Summary page 1.
- K041900: HC604 Cpap Humidifier, Fisher & Paykel Healthcare, Ltd. (2004) Summary page 1.

## Most influential descendants
- K173193: F&P SleepStyle (2018), 0 descendants of its own

## Recalls of this device
- Apr 22, 2013 · Class II · Z-1437-2013: Fisher and Paykel Healthcare is recalling the ICON CPAP units because there is a potential power issue on certain ICON CPAP. These ICON CPAP units could potentially become inoperable, which would resu

## Indications for use
The F&P ICON TM Series OPAP is for use on adult patients for the treatment of Obstructive Steep Apnea (OSA). The device is for use in the home or sleep laboratory.

Source page: https://510kreport.com/device/K094040
Methodology: https://510kreport.com/methodology