510(k) · Cleared

Cleared

Snor-X Mouth Guard

K954324510(k) TraditionalCleared Oct 17, 199529-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

Snorex, Inc. · LRK Device, Anti-Snoring

Cleared on Oct 17, 1995 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 27 later devices descend from it.

Decided: Oct 17, 1995
Review: 29 days
Class: Class II
Product code: LRK
Recalls: None
Predicates: 0

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

This deviceK954324 Snor-X Mouth GuardSnorex, Inc. · 1995
Descendant · cites it directly · 23 of its ownK972023 Sleep-in Bone Screw SystemInfluence, Inc. · 1997
Descendant · 2 generations on · 16 of its ownK981677 Repose Bone Screw SystemInfluence, Inc. · 1999 · Recalled
Descendant · 2 generations on · 15 of its ownK101060 Siesta Medical, Inc., Prelude Tongue Suspension SystemSiesta Medical, Inc. · 2010
Descendant · 3 generations on · 14 of its ownK103179 Prelude II Tounge Suspension SystemSiesta Medical, Inc. · 2010
Descendant · 4 generations on · 13 of its ownK110127 Prelude Iii Tongue Suspension SystemSiesta Medical, Inc. · 2011

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

1997high 5 (2012) · low 0 (1998)2026

Most influential descendants

Showing 5 of 27 · See all

K972023Sleep-in Bone Screw SystemInfluence, Inc. · 1997 · cites it directly23descendants
K981677Repose Bone Screw SystemInfluence, Inc. · 1999 · 2 generations on16descendants
K101060Siesta Medical, Inc., Prelude Tongue Suspension SystemSiesta Medical, Inc. · 2010 · 2 generations on15descendants
K103179Prelude II Tounge Suspension SystemSiesta Medical, Inc. · 2010 · 3 generations on14descendants
K110127Prelude Iii Tongue Suspension SystemSiesta Medical, Inc. · 2011 · 4 generations on13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K954324	Snor-X Mouth Guard	Snorex, Inc.	1995	—
+1	K972023	Sleep-in Bone Screw System	Influence, Inc.	1997	—
+2	K981677	Repose Bone Screw System	Influence, Inc.	1999	2
+2	K101060	Siesta Medical, Inc., Prelude Tongue Suspension System	Siesta Medical, Inc.	2010	—
+3	K103179	Prelude II Tounge Suspension System	Siesta Medical, Inc.	2010	—
+4	K110127	Prelude Iii Tongue Suspension System	Siesta Medical, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1999	1	0
2002	1	0
2004	1	0
2008	1	0
2010	2	0
2011	2	0
2012	5	0
2013	2	0
2014	2	0
2018	2	0
2019	1	0
2020	2	0
2021	2	0
2022	1	0
2023	1	0

FIG. 1 — Lineage of K954324, 1995–2023Source: 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (27)

See all 27

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

Number	Device	Applicant	Decided	Descendants
K972023	Sleep-in Bone Screw System	Influence, Inc.	1997	23
K081965	Mpowrx Snoring Solution	Mpowrx Health and Wellness Products, Inc.	2008	2

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, K972023 (Influence, Inc., 1997) has gone furthest, with 23 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/K954324 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954324: Snor-X Mouth Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954324

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Record history

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