510(k) · Cleared

Cleared

Snoremaster

K954128510(k) TraditionalCleared Oct 2, 199531-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

D.D.S., Inc. · LRK Device, Anti-Snoring

Cleared on Oct 2, 1995 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 29 later devices descend from it.

Decided: Oct 2, 1995
Review: 31 days
Class: Class II
Product code: LRK
Recalls: None
Predicates: 0

29 later devices descend from it, 3 citing it directly.

This deviceK954128 SnoremasterD.D.S., Inc. · 1995
Descendant · cites it directly · 26 of its ownK112205 Snorerx 9.0Consumer Health Products, Inc. · 2011
Descendant · 2 generations on · 22 of its ownK153200 SnoreRxApnea Sciences Corporation · 2016
Descendant · 3 generations on · 21 of its ownK170825 SnoreRxApnea Sciences Corporation · 2017
Descendant · cites it directly · 4 of its ownK113569 ApnearxApnea Science Corporation · 2012
Descendant · 4 generations on · 3 of its ownK233850 Difiney Anti Snoring DeviceFissiontech, LLC · 2024

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2011high 6 (2025) · low 0 (2013)2026

Most influential descendants

Showing 5 of 29 · See all

K112205Snorerx 9.0Consumer Health Products, Inc. · 2011 · cites it directly26descendants
K153200SnoreRxApnea Sciences Corporation · 2016 · 2 generations on22descendants
K170825SnoreRxApnea Sciences Corporation · 2017 · 3 generations on21descendants
K113569ApnearxApnea Science Corporation · 2012 · cites it directly4descendants
K233850Difiney Anti Snoring DeviceFissiontech, LLC · 2024 · 4 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K954128	Snoremaster	D.D.S., Inc.	1995	—
+1	K112205	Snorerx 9.0	Consumer Health Products, Inc.	2011	—
+2	K153200	SnoreRx	Apnea Sciences Corporation	2016	—
+3	K170825	SnoreRx	Apnea Sciences Corporation	2017	—
+1	K113569	Apnearx	Apnea Science Corporation	2012	—
+4	K233850	Difiney Anti Snoring Device	Fissiontech, LLC	2024	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	2	0
2014	1	0
2016	2	0
2017	1	0
2018	2	0
2019	1	0
2020	1	0
2021	3	0
2023	1	0
2024	2	0
2025	6	0
2026	6	0

FIG. 1 — Lineage of K954128, 1995–2026Source: 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

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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? (29)

See all 29

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

Number	Device	Applicant	Decided	Descendants
K112205	Snorerx 9.0	Consumer Health Products, Inc.	2011	26
K113569	Apnearx	Apnea Science Corporation	2012	4
K113022	Puresleep	Sleep Science Partners, Inc.	2012	1

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, K112205 (Consumer Health Products, Inc., 2011) has gone furthest, with 26 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/K954128 · printed Nov 5, 2026

Cite this page

510(k) Report. “K954128: Snoremaster.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954128

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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