510(k) · Cleared

Cleared

Snorerx 9.0

K112205510(k) AbbreviatedCleared Nov 16, 2011107-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

Consumer Health Products, Inc. · LRK Device, Anti-Snoring

Cleared on Nov 16, 2011 as substantially equivalent to K103004 (Ranir, LLC, 2011) and 3 other predicates after a 107-day review. Its family tree reaches back 3 generations to 2007. 26 later devices descend from it.

Decided: Nov 16, 2011
Review: 107 days
Class: Class II
Product code: LRK
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K071404 (2007). 8 ancestors in all, the oldest K882303 (1989). 26 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK071404 Sleep Right - Select, Low Profile and AdvancePower Products, Inc.-Splintek · 2007
2 generations backK100545 SleeprightPower Products, Inc.-Splintek · 2010
1 generation backK103004 Snore GuardRanir, LLC · 2011
This deviceK112205 Snorerx 9.0Consumer Health Products, Inc. · 2011
Descendant · cites it directly · 22 of its ownK153200 SnoreRxApnea Sciences Corporation · 2016
Descendant · 2 generations on · 21 of its ownK170825 SnoreRxApnea Sciences Corporation · 2017
Descendant · cites it directly · 4 of its ownK113569 ApnearxApnea Science Corporation · 2012
Descendant · 3 generations on · 3 of its ownK233850 Difiney Anti Snoring DeviceFissiontech, LLC · 2024
Descendant · 3 generations on · 3 of its ownK191618 SleepTight Mouthpiece STZMichael D Williams Dds PA · 2019

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2012high 6 (2025) · low 0 (2013)2026

Most influential descendants

Showing 5 of 26 · See all

K153200SnoreRxApnea Sciences Corporation · 2016 · cites it directly22descendants
K170825SnoreRxApnea Sciences Corporation · 2017 · 2 generations on21descendants
K113569ApnearxApnea Science Corporation · 2012 · cites it directly4descendants
K233850Difiney Anti Snoring DeviceFissiontech, LLC · 2024 · 3 generations on3descendants
K191618SleepTight Mouthpiece STZMichael D Williams Dds PA · 2019 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K071404	Sleep Right - Select, Low Profile and Advance	Power Products, Inc.-Splintek	2007	—
−2	K100545	Sleepright	Power Products, Inc.-Splintek	2010	—
−1	K103004	Snore Guard	Ranir, LLC	2011	—
0 (this device)	K112205	Snorerx 9.0	Consumer Health Products, Inc.	2011	—
+1	K153200	SnoreRx	Apnea Sciences Corporation	2016	—
+2	K170825	SnoreRx	Apnea Sciences Corporation	2017	—
+1	K113569	Apnearx	Apnea Science Corporation	2012	—
+3	K233850	Difiney Anti Snoring Device	Fissiontech, LLC	2024	—
+3	K191618	SleepTight Mouthpiece STZ	Michael D Williams Dds PA	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1995	2	0
1998	1	0
2010	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	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 K112205, 2007–2026Source: 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? (4)

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
*	K103004	Snore Guard Summary page 1 …Anti-Snoring Device, 21 CERZ, 872.5570 NAM: DEVICE Class 11 CLASSIFICATION: PRODUCT CODE LRK PREDICATE DEVICES: SnoreGuard (KI103004), Silencer (K(954530), SnoreControl (K963591), SnoreMaster (K(954128) Substantially Equivalent To:…	Ranir, LLC	2011	—
*	K954530	The Silencer Summary page 1 …evice, 21 CERZ, 872.5570 NAM: DEVICE Class 11 CLASSIFICATION: PRODUCT CODE LRK PREDICATE DEVICES: SnoreGuard (KI103004), Silencer (K(954530), SnoreControl (K963591), SnoreMaster (K(954128) Substantially Equivalent To: The Consumer Health…	Silent Knights Ventures, Inc.	1995	—
*	K963591	Snoring Control Device Summary page 1 …Class 11 CLASSIFICATION: PRODUCT CODE LRK PREDICATE DEVICES: SnoreGuard (KI103004), Silencer (K(954530), SnoreControl (K963591), SnoreMaster (K(954128) Substantially Equivalent To: The Consumer Health Products SnoreRx NS 9.0 is substantially equivale…	Kenneth Hilsen	1998	—
*	K954128	Snoremaster Summary page 1 …ATION: PRODUCT CODE LRK PREDICATE DEVICES: SnoreGuard (KI103004), Silencer (K(954530), SnoreControl (K963591), SnoreMaster (K(954128) Substantially Equivalent To: The Consumer Health Products SnoreRx NS 9.0 is substantially equivalent in intended use, pri…	D.D.S., Inc.	1995	—

Also cleared against K103004: 1 other device →

What descends from it? (26)

See all 26

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

Number	Device	Applicant	Decided	Descendants
K153200	SnoreRx	Apnea Sciences Corporation	2016	22
K113569	Apnearx	Apnea Science Corporation	2012	4

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 4 years and passes through 3 companies; a new generation was cleared every 9 months on median.
None of the 8 ancestors has a recall.
Of its descendants, K153200 (Apnea Sciences Corporation, 2016) has gone furthest, with 22 descendants of its own.
1 other device also cites its predicate K103004.

How does its category compare?

All LRK devices

LRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

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?

The Consumer Health Products "SnoreRx NS 9.0" is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K112205 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112205: Snorerx 9.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112205

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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