# K061236: Flexifit HC432 Full Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Aug 29, 2006 after 118 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 K003894 (2001). 7 ancestors in all.
25 later devices descend from it; 3 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)
- K040506: Flexifil Series HC431 Full Face Mask, Model HC431A, Fisher & Paykel Healthcare, Ltd. (2004) Summary page 1.
- K033087: Oracle Oral Mask, Model HC451A, Fisher & Paykel Healthcare, Ltd. (2004) Summary page 1.

## Most influential descendants
- K063036: Opus HC482 Direct Nasal Mask (2006), 24 descendants of its own
- K080209: Fisher and Paykel Healthcare Zest Nasal Mask (2008), 15 descendants of its own
- K083832: Zest Nasal Mask (2009), 14 descendants of its own
- K120027: Pilairo Nasal Pillows Mask (2012), 7 descendants of its own
- K161412: F&P Brevida™ Nasal Pillows Mask (2017), 6 descendants of its own

## Indications for use
The Flexifit HC432 Full Face Mask is intended for multiple patient or single patient adult use by individuals who have been diagnosed by a physician as requiring CPAP or Bilevel ventilator treatment in the home, hospital or other clinical setting.

Source page: https://510kreport.com/device/K061236
Methodology: https://510kreport.com/methodology