510(k) · Cleared

Cleared

H&M Anti-Snoring Device

K882303510(k) TraditionalCleared Apr 14, 1989315-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

Hays & Meade, Inc. · LRK Device, Anti-Snoring

Cleared on Apr 14, 1989 after a 315-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 202 later devices descend from it.

Decided: Apr 14, 1989
Review: 315 days
Class: Class II
Product code: LRK
Recalls: None
Predicates: 0

202 later devices descend from it, 7 citing it directly.

This deviceK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
Descendant · cites it directly · 152 of its ownK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
Descendant · 2 generations on · 109 of its ownK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
Descendant · 2 generations on · 95 of its ownK972061 TOAW. Keith Thornton, D.D.S. · 1997
Descendant · 3 generations on · 86 of its ownK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
Descendant · 2 generations on · 75 of its ownK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003

Showing 5 of 202 descendants. See all descendants

Descendants cleared per year

1996high 16 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 202 · See all

K962516Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996 · cites it directly152descendants
K042161Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004 · 2 generations on109descendants
K972061TOAW. Keith Thornton, D.D.S. · 1997 · 2 generations on95descendants
K050592Somnomed Mas RxaSomnomed, Ltd. · 2005 · 3 generations on86descendants
K022891The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003 · 2 generations on75descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K882303	H&M Anti-Snoring Device	Hays & Meade, Inc.	1989	—
+1	K962516	Tap Anti-Snoring Device	Nellcor Puritan Bennett, Inc.	1996	—
+2	K042161	Anti-Snoring/Sleep Apnea Device	Rj & VK Bird Pty, Ltd.	2004	—
+2	K972061	TOA	W. Keith Thornton, D.D.S.	1997	—
+3	K050592	Somnomed Mas Rxa	Somnomed, Ltd.	2005	—
+2	K022891	The Breathe EZ Anti-Snoring Device	D&S Redhage	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	1	0
1998	2	0
1999	1	0
2002	2	0
2003	3	0
2004	1	0
2005	3	0
2006	9	0
2007	2	0
2008	2	0
2009	6	0
2010	6	0
2011	11	0
2012	14	0
2013	10	0
2014	12	0
2015	7	0
2016	11	0
2017	10	0
2018	7	0
2019	10	0
2020	10	0
2021	11	0
2022	5	0
2023	7	0
2024	11	0
2025	16	0
2026	11	0

FIG. 1 — Lineage of K882303, 1989–2026Source: 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? (202)

See all 202

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

Number	Device	Applicant	Decided	Descendants
K962516	Tap Anti-Snoring Device	Nellcor Puritan Bennett, Inc.	1996	152
K014079	DR. Hays Bite Guard	Inventive Resources, Inc.	2002	33
K102118	Snore Guard Advance	Ranir, LLC	2010	29
K991449	Snore-Aid Plus	Dental Imagineers, LLC	1999	1
K060122	Sleep Splint	Nakagawa Dental Clinic	2006	0
K022284	Snore-Aid Max	Dental Imagineers, LLC	2002	0
K980952	Snore-Cure Anti-Snoring Appliance	ORTHO-TAIN, Inc.	1998	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, K962516 (Nellcor Puritan Bennett, Inc., 1996) has gone furthest, with 152 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/K882303 · printed Nov 6, 2026

Cite this page

510(k) Report. “K882303: H&M Anti-Snoring Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K882303

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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