510(k) · Cleared

Cleared

TAP

K964516510(k) TraditionalCleared Jan 24, 199780-day reviewClass II21 CFR 872.5570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nellcor Puritan Bennett, Inc. · LRK Device, Anti-Snoring

Cleared on Jan 24, 1997 as substantially equivalent to K960673 (Snorefree, Inc., 1996) and 1 other predicate after an 80-day review. Its family tree reaches back 1 generation to 1993.

Decided: Jan 24, 1997
Review: 80 days
Class: Class II
Product code: LRK
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K926382 (1993). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK926382 TherasnoreDr. Thomas E. Meade · 1993
This deviceK964516 TAPNellcor Puritan Bennett, Inc. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K926382	Therasnore	Dr. Thomas E. Meade	1993	—
0 (this device)	K964516	TAP	Nellcor Puritan Bennett, Inc.	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

FIG. 1 — Lineage of K964516, 1993–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LRK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LRK device

#1 K252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for…score 16.3 · 9 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K960673	OSAP Summary page 3 …or Trade Name: TAP Common/Usual Name: Oral Appliance - anti-snoring device Classification Name: Anti-snoring device Device: TAP Predicate Devices: SnoreFree - OSAP - K960673 Distar, Inc. - TheraSnore - K926382 Dental Services group - Adjustable PM Positioner - K# unknown [Device Description: The TA…	Snorefree, Inc.	1996	—
*	K926382	Therasnore Summary page 3 …e: Oral Appliance - anti-snoring device Classification Name: Anti-snoring device Device: TAP Predicate Devices: SnoreFree - OSAP - K960673 Distar, Inc. - TheraSnore - K926382 Dental Services group - Adjustable PM Positioner - K# unknown [Device Description: The TAP anti-snoring device is comprised of…	Dr. Thomas E. Meade	1993	—
*	—	Adjustable PM Positioner Named without a submission number			—

Also cleared against K960673: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
2 other devices also cite its predicate K960673.

How does its category compare?

All LRK devices

LRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LRK

14in 2025

2007high 14 (2025) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LRK

107in 2025

2007high 254 (2024) · low 80 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LRK

1in 2025

2007high 2 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LRK

653in 2025

2007high 653 (2025) · low 0 (2007)2025

MAUDE reports naming product code LRK, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	0
2008	3	109	0	1
2009	3	88	2	11
2010	8	195	0	7
2011	10	134	0	69
2012	10	142	0	445
2013	9	233	0	72
2014	11	219	0	49
2015	6	117	0	28
2016	10	157	0	18
2017	7	170	0	32
2018	10	200	0	61
2019	13	150	0	56
2020	5	80	0	24
2021	10	126	0	49
2022	11	154	0	40
2023	5	156	0	50
2024	6	254	0	185
2025	14	107	1	653
2026	10	63	1	—

What is it indicated for?

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

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K964516 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964516: TAP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964516

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026

TAP