510(k) · Cleared

Cleared

The Silencer

K954530510(k) TraditionalCleared Oct 30, 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

Silent Knights Ventures, Inc. · LRK Device, Anti-Snoring

Cleared on Oct 30, 1995 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 55 later devices descend from it.

Decided: Oct 30, 1995
Review: 31 days
Class: Class II
Product code: LRK
Recalls: None
Predicates: 0

55 later devices descend from it, 5 citing it directly.

This deviceK954530 The SilencerSilent Knights Ventures, Inc. · 1995
Descendant · cites it directly · 35 of its ownK033822 Respironics Custom I Oral ApplianceRespironics, Inc. · 2004
Descendant · cites it directly · 26 of its ownK112205 Snorerx 9.0Consumer Health Products, Inc. · 2011
Descendant · cites it directly · 23 of its ownK033823 Respironics Custom II Oral ApplianceRespironics, Inc. · 2004
Descendant · 2 generations on · 22 of its ownK153200 SnoreRxApnea Sciences Corporation · 2016
Descendant · cites it directly · 22 of its ownK061688 Anti-Snoring / Sleep Apnea DeviceTomed Dr. Toussaint GmbH · 2006

Showing 5 of 55 descendants. See all descendants

Descendants cleared per year

2004high 7 (2012) · low 0 (2005)2026

Most influential descendants

Showing 5 of 55 · See all

K033822Respironics Custom I Oral ApplianceRespironics, Inc. · 2004 · cites it directly35descendants
K112205Snorerx 9.0Consumer Health Products, Inc. · 2011 · cites it directly26descendants
K033823Respironics Custom II Oral ApplianceRespironics, Inc. · 2004 · cites it directly23descendants
K153200SnoreRxApnea Sciences Corporation · 2016 · 2 generations on22descendants
K061688Anti-Snoring / Sleep Apnea DeviceTomed Dr. Toussaint GmbH · 2006 · cites it directly22descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K954530	The Silencer	Silent Knights Ventures, Inc.	1995	—
+1	K033822	Respironics Custom I Oral Appliance	Respironics, Inc.	2004	—
+1	K112205	Snorerx 9.0	Consumer Health Products, Inc.	2011	—
+1	K033823	Respironics Custom II Oral Appliance	Respironics, Inc.	2004	—
+2	K153200	SnoreRx	Apnea Sciences Corporation	2016	—
+1	K061688	Anti-Snoring / Sleep Apnea Device	Tomed Dr. Toussaint GmbH	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2006	3	0
2009	1	0
2010	1	0
2011	2	0
2012	7	0
2013	1	0
2014	3	0
2016	5	0
2017	1	0
2018	4	0
2019	2	0
2020	2	0
2021	4	0
2023	2	0
2024	2	0
2025	7	0
2026	6	0

FIG. 1 — Lineage of K954530, 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

Get a 510(k) Report

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? (55)

See all 55

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

Number	Device	Applicant	Decided	Descendants
K033822	Respironics Custom I Oral Appliance	Respironics, Inc.	2004	35
K112205	Snorerx 9.0	Consumer Health Products, Inc.	2011	26
K033823	Respironics Custom II Oral Appliance	Respironics, Inc.	2004	23
K061688	Anti-Snoring / Sleep Apnea Device	Tomed Dr. Toussaint GmbH	2006	22
K060122	Sleep Splint	Nakagawa Dental Clinic	2006	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?

Of its descendants, K033822 (Respironics, Inc., 2004) has gone furthest, with 35 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/K954530 · printed Nov 5, 2026

Cite this page

510(k) Report. “K954530: The Silencer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954530

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