# K081029: Sleepstyle 200 Auto Series HC254

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Sep 12, 2008 after 154 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: 4 generations back to K952292 (1995). 7 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040941: Cpap Humidifier, Model HC234 (and Related Accessories), Fisher & Paykel Healthcare, Ltd. (2004) Summary page 1.

## Most influential descendants
- K110316: Infosend GSM (2011), 1 descendant of its own
- K094040: F&P Icon Series Cpap (2010), 1 descendant of its own
- K173193: F&P SleepStyle (2018), 0 descendants of its own
- K161686: F&P InfoSmart (2017), 0 descendants of its own

## Indications for use
The Sleepstyle TM 200 Auto Series HC254 is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The device is for use in the home or sleep laboratory.

Source page: https://510kreport.com/device/K081029
Methodology: https://510kreport.com/methodology