# K003894: Oracle Oral Mask

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Jun 25, 2001 after 189 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
No predicates in its family tree.
41 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K023559: Fisher & Paykel Healthecare Oracle Oral Mask (2003), 40 descendants of its own
- 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

## 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

Source page: https://510kreport.com/device/K003894
Methodology: https://510kreport.com/methodology