# K031935: Tiara Medical Systems Advantage II Nasal Mask, Models TMS-2520 and TMS-2530

- Pathway: 510(k) (Traditional)
- Applicant: Tiara Medical Systems, Inc.
- Decided: Mar 3, 2004 after 254 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 K980721 (1998). 2 ancestors in all.
23 later devices descend from it; 2 cite it directly.
8 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012207: Advantage Nasal Mask, Small, Advantage Nasal Mask. Regular, Models TMS-2520, TMS 2530, Tiara Medical Systems, Inc. (2001) Summary page 1.
- K980721: Sullivan Autoset, Resmed, Ltd. (1998) Summary page 1.

## Most influential descendants
- K043382: TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840 (2005), 21 descendants of its own
- K060273: Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model NO.53836,Large,Model NO. 53837 (2006), 20 descendants of its own
- K132887: Airfit N10 (2013), 7 descendants of its own
- K153673: AirFit N20 (2016), 6 descendants of its own
- K063806: Sleepnet Mojo -NV Full Face Mask, Non-Vented (2007), 6 descendants of its own

## Indications for use
The Tiara Medical Systems Advantage II Nasal Mask is intended to be used with continuous positive airway pressure devices (CPAP), operating at or above 3 cmH20 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 airway pressure has been prescribed.

Source page: https://510kreport.com/device/K031935
Methodology: https://510kreport.com/methodology