# K031883: Lyra Nasal Mask

- Pathway: 510(k) (Traditional)
- Applicant: Sensor Medics Corp.
- Decided: Aug 25, 2003 after 68 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 K022465 (2003). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022465: Modification to Nasal-Aire, Innomed Technologies (2003) Summary page 2.

## Most influential descendants
- K034053: TMS Snapp Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030 & TMS-3040 (2004), 1 descendant of its own
- K061099: Breathx Nasal Pillow and Mask System, Model 011-0003 (2006), 0 descendants of its own
- 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 LyraTM Nasal Mask is intended for use with devices that deliver Continuous Positive Airway Pressure (CPAP) and bi-level positive airway pressure in treating adult patients.

Source page: https://510kreport.com/device/K031883
Methodology: https://510kreport.com/methodology