# K023559: Fisher & Paykel Healthecare Oracle Oral Mask

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Jun 12, 2003 after 232 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: 1 generation back to K003894 (2001). 1 ancestor in all.
40 later devices descend from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003894: Oracle Oral Mask, Fisher & Paykel Healthcare, Ltd. (2001)

## Most influential descendants
- K033087: Oracle Oral Mask, Model HC451A (2004), 39 descendants of its own
- K040506: Flexifil Series HC431 Full Face Mask, Model HC431A (2004), 38 descendants of its own
- 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

## Indications for use
The Fisher & Paykel Healthcare Oracle Oral Mask is an accessory to a Noncontinuous ventilator (IPPB) as per 73 BZD, 21 CFR S868.5905. The Oral 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 orally. The Oral Mask is a reusable device for use on the prescription of a suitably qualified physician. The Oral Mask may be reprocessed for multi-patient use.

Source page: https://510kreport.com/device/K023559
Methodology: https://510kreport.com/methodology