# K093124: Puresom Nasal Mask-Small, Puresom Nasal Mask-Medium, Puresom Nasal Mask-Large, Models 11924-01, 11924-02, 11924-03

- Pathway: 510(k) (Special)
- Applicant: Cardinal Health 207, Inc.
- Decided: Mar 10, 2010 after 159 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: 8 generations back to K982530 (1998). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031935: Tiara Medical Systems Advantage II Nasal Mask, Models TMS-2520 and TMS-2530, Tiara Medical Systems, Inc. (2004) Summary page 2.
- K012207: Advantage Nasal Mask, Small, Advantage Nasal Mask. Regular, Models TMS-2520, TMS 2530, Tiara Medical Systems, Inc. (2001) Summary page 2.
- K090490: Mirage Echo, Resmed Corp (2009) Summary page 2.

## Indications for use
The Puresom Nasal (CPAP) Mask system is for use with continuous positive airway pressure devices (CPAP), operating at or above 3cmH2O for the treatment of obstructive sleep apnea. The mask is intended for single patient use and can be used in the home or in a hospital/ institutional environment. The mask is to be used on adult patients (>30Kg) for whom continuous positive pressure airway has been prescribed.

Source page: https://510kreport.com/device/K093124
Methodology: https://510kreport.com/methodology