# K023670: Single Use Oral Mask, Model HC455A

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Jun 12, 2003 after 224 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K023894: ST Aia-Pack Afp Enzyme Immunoassay, Tosoh Medics, Inc. (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Fisher & Paykel Healthcare Single Use 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. It constitutes the patient to ventilator interface in a noncontinuous ventilator system. The device administers positive airway pressure orally. The Oral Mask is for single patient use, for up to 30 days, on the prescription of a physician.

Source page: https://510kreport.com/device/K023670
Methodology: https://510kreport.com/methodology