# K964516: TAP

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Jan 24, 1997 after 80 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: 1 generation back to K926382 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960673: OSAP, Snorefree, Inc. (1996) Summary page 3.
- K926382: Therasnore, Dr. Thomas E. Meade (1993) Summary page 3.
- (no number) Adjustable PM Positioner: named in the summary without a submission number

## Indications for use
Indicated Use -- The TAP is intended to reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea, OSA. Target population - - Adult patients Environment of Use - - Home and sleep laboratories

Source page: https://510kreport.com/device/K964516
Methodology: https://510kreport.com/methodology