# K022891: The Breathe EZ Anti-Snoring Device

- Pathway: 510(k) (Traditional)
- Applicant: D&S Redhage
- Decided: Feb 19, 2003 after 173 days
- Product code: LRK (Device, Anti-Snoring)
- Device class: 2
- Regulation: 21 CFR 872.5570
- 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 K882303 (1989). 7 ancestors in all.
75 later devices descend from it; 3 cite it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991948: DR. B'S Mouthpiece, Model 32129-10002, Snore - Ezzer (1999) Summary page 1.
- K963063: Snore Tec, Marketing Technologies, Inc. (1997) Summary page 1.
- K962516: Tap Anti-Snoring Device, Nellcor Puritan Bennett, Inc. (1996) Summary page 1.
- K972061: TOA, W. Keith Thornton, D.D.S. (1997) Summary page 2.

## Most influential descendants
- K030440: Oasys-Oral Airway System (2003), 65 descendants of its own
- K060388: Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment (2006), 51 descendants of its own
- K061732: TAP-T (2006), 32 descendants of its own
- K103076: Dynaflex (2011), 29 descendants of its own
- K130130: Atg/SM-Osa Appliances (2013), 17 descendants of its own

## Indications for use
The Breath EZ Anti-Snoring Device is intended to reduce or alleviate snoring by maintaining an open airway and to prevent bruxing, clenching and grinding of the teeth while sleeping.

Source page: https://510kreport.com/device/K022891
Methodology: https://510kreport.com/methodology