# K043382: TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840

- Pathway: 510(k) (Traditional)
- Applicant: Tiara Medical Systems, Inc.
- Decided: Jan 19, 2005 after 41 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: 3 generations back to K936047 (1995). 8 ancestors in all.
21 later devices descend from it; 1 cites it directly.
8 of 30 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 1.
- K020759: 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630 Medium, 7640 Small, 7650 Extra Small, 7660 Petit, Hans Rudolph, Inc. (2002) Summary page 1.
- K002465: Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876, Respironics, Inc. (2000) Summary page 1.

## Most influential descendants
- 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
- K161978: AirFit N20 (2016), 5 descendants of its own

## Indications for use
The Tiara Medical Systems FULL ADVANTAGETM Full Face Mask is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure) for the treatment of adult obstructive sleep apnea. The mask is intended for single patient use and re-use in the home or hospital/institutional environment. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed.

Source page: https://510kreport.com/device/K043382
Methodology: https://510kreport.com/methodology