Altis Full Face Mask— 510(k) K261262
Substantially EquivalentRespironics, Inc.
FDA 510(k) clearance K261262 for Altis Full Face Mask, Substantially Equivalent on 2026-09-25. Applicant: Respironics, Inc.. Device class: 2.
Summary
The Altis Full Face Mask from Respironics, Inc. is filed under BZD, non-continuous ventilators (respirators). The record lists the mask under that ventilator code but doesn't say which therapy devices it's meant to be used with.
Class II, 21 CFR 868.5905. The Anesthesiology panel reviewed it as a Traditional 510(k).
Respironics filed from Murrysville, Pennsylvania. Review took 162 days (April 16 to September 25, 2026).
Clearance details
- Applicant
- Respironics, Inc.
- Product code
- Product code BZD
- Device class
- Class 2
- Regulation
- 21 CFR 868.5905
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Murrysville, PA, US
Recent devices under product code BZD
view allMore clearances from Respironics, Inc.
view allAdverse events under product code BZD
product code BZD- Death
- 4,440
- Injury
- 53,099
- Malfunction
- 213,222
- Other
- 17
- Total
- 270,778
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.