510(k) · Cleared

Cleared

Snore Tec

K963063510(k) TraditionalCleared Apr 14, 1997250-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

Marketing Technologies, Inc. · LRK Device, Anti-Snoring

Cleared on Apr 14, 1997 after a 250-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 76 later devices descend from it.

Decided: Apr 14, 1997
Review: 250 days
Class: Class II
Product code: LRK
Recalls: None
Predicates: 0

76 later devices descend from it, 2 citing it directly.

This deviceK963063 Snore TecMarketing Technologies, Inc. · 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 · 2 generations on · 51 of its ownK060388 Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with…Airway Management, Inc. · 2006
Descendant · 3 generations on · 32 of its ownK061732 TAP-TAirway Management, Inc. · 2006
Descendant · 4 generations on · 29 of its ownK103076 DynaflexDyna Flex · 2011

Showing 5 of 76 descendants. See all descendants

Descendants cleared per year

2003high 6 (2011) · low 0 (2004)2026

Most influential descendants

Showing 5 of 76 · 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 · 2 generations on51descendants
K061732TAP-TAirway Management, Inc. · 2006 · 3 generations on32descendants
K103076DynaflexDyna Flex · 2011 · 4 generations on29descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K963063	Snore Tec	Marketing Technologies, Inc.	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	—
+2	K060388	Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment	Airway Management, Inc.	2006	—
+3	K061732	TAP-T	Airway Management, Inc.	2006	—
+4	K103076	Dynaflex	Dyna Flex	2011	—

Descendants by year cleared

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

FIG. 1 — Lineage of K963063, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (76)

See all 76

2 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

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?

Of its descendants, K022891 (D&S Redhage, 2003) has gone furthest, with 75 descendants of its own.

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	—

https://510kreport.com/device/K963063 · printed Nov 5, 2026

Cite this page

510(k) Report. “K963063: Snore Tec.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963063

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026