# K051583: Tiara Snapp X Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030, TMS- 3040, TMS-3050

- Pathway: 510(k) (Special)
- Applicant: Tiara Medical Systems, Inc.
- Decided: Nov 4, 2005 after 142 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: 4 generations back to K982530 (1998). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K034053: TMS Snapp Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030 & TMS-3040, Tiara Medical Systems, Inc. (2004) Summary page 1.
- K042403: Mirage Swift, Resmed, Ltd. (2004) Summary page 1.

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

Source page: https://510kreport.com/device/K051583
Methodology: https://510kreport.com/methodology