510(k) · Cleared

Cleared

Healthy Sleep Appliance

K123410510(k) TraditionalCleared Apr 5, 2013151-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

Healthy Sleep Dental Laboratory · LRK Device, Anti-Snoring

Cleared on Apr 5, 2013 as substantially equivalent to K083209 (Specialty Appliance Works, Inc., 2009) after a 151-day review. Its family tree reaches back 2 generations to 2007.

Decided: Apr 5, 2013
Review: 151 days
Class: Class II
Product code: LRK
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K070327 (2007). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK070327 Removable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch…Sybron Dental Specialties, Inc. · 2007
1 generation backK083209 Acrylic Herbst Splint ApplianceSpecialty Appliance Works, Inc. · 2009
This deviceK123410 Healthy Sleep ApplianceHealthy Sleep Dental Laboratory · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K070327	Removable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch Snorinator	Sybron Dental Specialties, Inc.	2007	—
−1	K083209	Acrylic Herbst Splint Appliance	Specialty Appliance Works, Inc.	2009	—
0 (this device)	K123410	Healthy Sleep Appliance	Healthy Sleep Dental Laboratory	2013	—

FIG. 1 — Lineage of K123410, 2007–2013Source: 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? (1)

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
*	K083209	Acrylic Herbst Splint Appliance Summary page 1 …LRK - intraoral devices for snoring and OSA 21 CFR 872.5570 Class 2 Predicate Devices: K083209 - Acrylic Herbst Splint Appliance Device Description:I The Healthy Sleep Appliance is a mandibular repositioning oral appliance…	Specialty Appliance Works, Inc.	2009	—

Also cleared against K083209: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 6 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
None of the 2 ancestors has a recall.
6 other devices also cite its predicate K083209.

How does its category compare?

All LRK devices

LRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Healthy Sleep Appliance is intended for use in patients 18 years of age or older for the reduction of snoring and mild to moderate obstructive sleep apnea.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123410 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123410: Healthy Sleep Appliance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123410

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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