# K034053: TMS Snapp Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030 & TMS-3040

- Pathway: 510(k) (Traditional)
- Applicant: Tiara Medical Systems, Inc.
- Decided: Jun 24, 2004 after 177 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: 2 generations back to K945938 (1996). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 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.
- K990659: Nasal Aire, Breathing Technologies Corp. (1999) Summary page 1.
- K022465: Modification to Nasal-Aire, Innomed Technologies (2003) Summary page 1.
- K031883: Lyra Nasal Mask, Sensor Medics Corp. (2003) Summary page 1.

## Most influential descendants
- K051583: Tiara Snapp X Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030, TMS- 3040, TMS-3050 (2005), 0 descendants of its own

## Indications for use
The Tiara Medical Systems SNAPP 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 SNAPP is intended for single patient use and can be used in the home or in a hospital/institutional environment. The SNAPP is to be used on adult patients (>30Kg) for whom continuous positive airway pressure has been prescribed.

Source page: https://510kreport.com/device/K034053
Methodology: https://510kreport.com/methodology