510(k) · Cleared

Cleared

TOA

K972061510(k) TraditionalCleared Aug 21, 199779-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

W. Keith Thornton, D.D.S. · LRK Device, Anti-Snoring

Cleared on Aug 21, 1997 as substantially equivalent to K962516 (Nellcor Puritan Bennett, Inc., 1996) and 2 other predicates after a 79-day review. Its family tree reaches back 2 generations to 1989. 95 later devices descend from it.

Decided: Aug 21, 1997
Review: 79 days
Class: Class II
Product code: LRK
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K882303 (1989). 4 ancestors in all. 95 later devices descend from it, 10 citing it directly.

By dateBy generation

Root · 2 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
1 generation backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
This deviceK972061 TOAW. Keith Thornton, D.D.S. · 1997
Descendant · cites it directly · 75 of its ownK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
Descendant · cites it directly · 65 of its ownK030440 Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003
Descendant · cites it directly · 51 of its ownK060388 Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with…Airway Management, Inc. · 2006
Descendant · cites it directly · 32 of its ownK061732 TAP-TAirway Management, Inc. · 2006
Descendant · 2 generations on · 29 of its ownK103076 DynaflexDyna Flex · 2011

Showing 5 of 95 descendants. See all descendants

Descendants cleared per year

1998high 8 (2012) · low 0 (1999)2026

Most influential descendants

Showing 5 of 95 · See all

K022891The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003 · cites it directly75descendants
K030440Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003 · cites it directly65descendants
K060388Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with AttachmentAirway Management, Inc. · 2006 · cites it directly51descendants
K061732TAP-TAirway Management, Inc. · 2006 · cites it directly32descendants
K103076DynaflexDyna Flex · 2011 · 2 generations on29descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K882303	H&M Anti-Snoring Device	Hays & Meade, Inc.	1989	—
−1	K962516	Tap Anti-Snoring Device	Nellcor Puritan Bennett, Inc.	1996	—
0 (this device)	K972061	TOA	W. Keith Thornton, D.D.S.	1997	—
+1	K022891	The Breathe EZ Anti-Snoring Device	D&S Redhage	2003	—
+1	K030440	Oasys-Oral Airway System	Mark Abramson, D.D.S., Inc.	2003	—
+1	K060388	Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment	Airway Management, Inc.	2006	—
+1	K061732	TAP-T	Airway Management, Inc.	2006	—
+2	K103076	Dynaflex	Dyna Flex	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2003	2	0
2005	2	0
2006	6	0
2008	1	0
2009	4	0
2010	2	0
2011	6	0
2012	8	0
2013	5	0
2014	5	0
2015	3	0
2016	6	0
2017	5	0
2018	4	0
2019	4	0
2020	6	0
2021	6	0
2022	3	0
2023	4	0
2024	3	0
2025	5	0
2026	4	0

FIG. 1 — Lineage of K972061, 1989–2026Source: 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
*	K962516	Tap Anti-Snoring Device Summary page 1 …Name: TOA Common/Usual Name: Oral Appliance - anti-snoring device Classification Name: Anti-snoring device Device: TOA Predicate Devices: Nellcor Puritan Bennett - TAP - K962516 SnoreFree - OSAP - K960673 Distar, Inc. - TheraSnore - K9263 82 [DevicerDescription: R The TOA Anti-snoring device is comprised…	Nellcor Puritan Bennett, Inc.	1996	—
*	K960673	OSAP Summary page 1 …: Oral Appliance - anti-snoring device Classification Name: Anti-snoring device Device: TOA Predicate Devices: Nellcor Puritan Bennett - TAP - K962516 SnoreFree - OSAP - K960673 Distar, Inc. - TheraSnore - K9263 82 [DevicerDescription: R The TOA Anti-snoring device is comprised of - * Lower tray fitted o…	Snorefree, Inc.	1996	—
*	K926382	Therasnore Summary page 1 …ce Classification Name: Anti-snoring device Device: TOA Predicate Devices: Nellcor Puritan Bennett - TAP - K962516 SnoreFree - OSAP - K960673 Distar, Inc. - TheraSnore - K9263 82 [DevicerDescription: R The TOA Anti-snoring device is comprised of - * Lower tray fitted over the lower teeth. * Upper tray fi…	Dr. Thomas E. Meade	1993	—

Also cleared against K962516: 12 other devices →

What descends from it? (95)

See all 95

10 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K022891	The Breathe EZ Anti-Snoring Device	D&S Redhage	2003	75
K030440	Oasys-Oral Airway System	Mark Abramson, D.D.S., Inc.	2003	65
K060388	Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment	Airway Management, Inc.	2006	51
K061732	TAP-T	Airway Management, Inc.	2006	32
K061688	Anti-Snoring / Sleep Apnea Device	Tomed Dr. Toussaint GmbH	2006	22
K062951	Tap Iii Anti-Snoring Device	Airway Management, Inc.	2006	15
K161980	Fuselier Intraoral Nighttime Device (FIND)	Fuselier Enterprises, LLC	2017	0
K162306	SomnoDent ALPHA	Somnomed, Inc.	2016	0
K051014	Silent Partner Series Osa Appliances	Dreamwrx Dental Laboratory	2005	0
K981744	Combination Toa with Nasal Mask Holder and Universal Nasal Mask Holder	W. Keith Thornton, D.D.S.	1998	0

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?

The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K022891 (D&S Redhage, 2003) has gone furthest, with 75 descendants of its own.
12 other devices also cite its predicate K962516.

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?

To reduce or alleviate night time snoring and obstructive sleep apnea (OSA)

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/K972061 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972061: TOA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972061

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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

TOA