# K062224: Respcare Hybrid AV Mask

- Pathway: 510(k) (Special)
- Applicant: Respcare, Inc.
- Decided: Aug 17, 2006 after 15 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 K052227 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052227: Respcare Face Mask, Respcare, Inc. (2005) Summary page 1.

## Indications for use
The RespCare Hybrid AV Mask is intended for use by adults (> 30 kg) as a patient interface for CPAP or Bi-Level positive-pressure ventilation devices for treatment of respiratory insufficiencies and obstructive sleep apnea. (Applies to the standard version): For homecare applications, the Hybrid AV Mask may be reused multiple times by a single patient. For institutional applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients. (Applies to the Disposable version): The Hybrid AV Disposable Mask is a single patient, single use interface.

Source page: https://510kreport.com/device/K062224
Methodology: https://510kreport.com/methodology