# K261262: Altis Full Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Sep 25, 2026 after 162 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: 11 generations back to K982530 (1998). 27 ancestors in all.
No later device cites it as a predicate yet.
2 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242547: AirFit F20 Mask System; AirFit F20 NM Mask System, Resmed Pty, Ltd. (2025) Summary page 5.

## Indications for use
The Altis Full Face Mask is intended to provide an interface for the application of non-invasive positive airway pressure (PAP) therapy. The mask is intended for single-patient reuse in the home environment and healthcare facilities and/or hospital environments. The mask is to be used by adult patients aged 22 years and older weighing more than 66lb (30kg) for whom non-invasive PAP therapy has been prescribed. The device is not intended for critical care patients.

Source page: https://510kreport.com/device/K261262
Methodology: https://510kreport.com/methodology