# K972061: TOA

- Pathway: 510(k) (Traditional)
- Applicant: W. Keith Thornton, D.D.S.
- Decided: Aug 21, 1997 after 79 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: 2 generations back to K882303 (1989). 4 ancestors in all.
95 later devices descend from it; 10 cite it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962516: Tap Anti-Snoring Device, Nellcor Puritan Bennett, Inc. (1996) Summary page 1.
- K960673: OSAP, Snorefree, Inc. (1996) Summary page 1.
- K926382: Therasnore, Dr. Thomas E. Meade (1993) Summary page 1.

## Most influential descendants
- K022891: The Breathe EZ Anti-Snoring Device (2003), 75 descendants of its own
- 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

## Indications for use
To reduce or alleviate night time snoring and obstructive sleep apnea (OSA)

Source page: https://510kreport.com/device/K972061
Methodology: https://510kreport.com/methodology