# K071915: Cpap Mask

- Pathway: 510(k) (Traditional)
- Applicant: Arcimed Laboratories, LLC
- Decided: May 14, 2008 after 308 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: 5 generations back to K982530 (1998). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063122: Mirage Quattro Full Face Mask, Resmed, Ltd. (2007) Summary page 1.
- K950771: Disposable Adhesive Face Mask, Advanced Warming Systems, Inc. (1995) Summary page 1.
- K002465: Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876, Respironics, Inc. (2000) Summary page 1.

## Indications for use
A patient interface, face mask, for use with CPAP and bi-level systems used in the treatment of adult (>30 kg) OSA and / or ventilatory support. Two styles (with exhalation port and without exhalation port). Single use only < 24 hours.

Source page: https://510kreport.com/device/K071915
Methodology: https://510kreport.com/methodology