# K012207: Advantage Nasal Mask, Small, Advantage Nasal Mask. Regular, Models TMS-2520, TMS 2530

- Pathway: 510(k) (Special)
- Applicant: Tiara Medical Systems, Inc.
- Decided: Jul 23, 2001 after 7 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
No predicates in its family tree.
26 later devices descend from it; 3 cite it directly.
8 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K031935: Tiara Medical Systems Advantage II Nasal Mask, Models TMS-2520 and TMS-2530 (2004), 23 descendants of its own
- 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

## Indications for use
The Tiara Medical Systems Advantage™ Nasal Mask is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure), operating at or above 3 cmH,0 for the treatment of adult obstructive sleep apnea.

Source page: https://510kreport.com/device/K012207
Methodology: https://510kreport.com/methodology