# K040506: Flexifil Series HC431 Full Face Mask, Model HC431A

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: May 5, 2004 after 68 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003894 (2001). 6 ancestors in all.
38 later devices descend from it; 5 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023244: Mirage Full Face Mask Series 2, Resmed, Ltd. (2002) Summary page 1.
- K033087: Oracle Oral Mask, Model HC451A, Fisher & Paykel Healthcare, Ltd. (2004) Summary page 1.

## Most influential descendants
- K061236: Flexifit HC432 Full Face Mask (2006), 25 descendants of its own
- 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

## Recalls of this device
- Nov 24, 2006 · Not classified · Z-0974-2007: Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it ma
- Nov 24, 2006 · Not classified · Z-0970-2007: Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it ma
- Nov 24, 2006 · Not classified · Z-0971-2007: Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it ma
- Nov 24, 2006 · Not classified · Z-0973-2007: Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it ma
- Nov 24, 2006 · Not classified · Z-0969-2007: Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it ma
- Nov 24, 2006 · Not classified · Z-0972-2007: Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it ma

## Indications for use
The Fisher & Paykel Healthcare Flexifit TM Series HC431 Full Face Mask is an accessory to a Noncontinuous ventilator (IPPB) as per 73 BZD, 21 CFR §868.5905. The Flexifit TM Series HC431 Full Face Mask is indicated for use by adults requiring CPAP or Bilevel ventilator treatment in home, hospital and laboratory environments for the treatment of Obstructive Sleep Apnea (OSA). It constitutes the patient to ventilator interface in a noncontinuous ventilator system. The device administers positive airway pressure via a mask which covers the nose and mouth. The HC431 Full Face Mask is a multi-patient reusable device for use on the prescription of a suitably qualified physician.

Source page: https://510kreport.com/device/K040506
Methodology: https://510kreport.com/methodology