510(k) · Cleared

Cleared

Morpheus

K210636510(k) TraditionalCleared Feb 15, 2022361-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

S4S UK, Ltd. · LRK Device, Anti-Snoring

Cleared on Feb 15, 2022 after a 361-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided: Feb 15, 2022
Review: 361 days
Class: Class II
Product code: LRK
Recalls: None
Predicates: 0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K210636Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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.

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

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.

How does its category compare?

All LRK devices

LRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?

Morpheus is a prescription, patient-matched, mandibular repositioning device that is intended to reduce snoring or to treat mild to moderate obstructive sleep apnea. The device is intended for use by adult patients in either the home or sleep laboratory environment

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K210636 · printed Nov 5, 2026

Cite this page

510(k) Report. “K210636: Morpheus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K210636

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026