Cleared Traditional

Morpheus (K210636) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210636 · S4S UK , Ltd. · Dental device
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Feb 2022
Decision
361d
Days
Class 2
Risk

K210636 is an FDA 510(k) clearance for the Morpheus. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by S4S UK , Ltd. (Sheffield, GB). The FDA issued a Cleared decision on February 15, 2022 after a review of 361 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all S4S UK , Ltd. devices

Submission Details

510(k) Number K210636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2021
Decision Date February 15, 2022
Days to Decision 361 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
234d slower than avg
Panel avg: 127d · This submission: 361d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRK Device, Anti-snoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - LRK Device, Anti-snoring

All 80
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K210636.
Soundly Anti Snoring Device
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SmartGuard Anti-Snoring Device
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