Cleared Abbreviated

K190051 - TD Clip (FDA 510(k) Clearance)

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K190051 · Zephyr Sleep Technologies, Inc. · Dental device
Jun 2019
Decision
147d
Days
Class 2
Risk

K190051 is an FDA 510(k) clearance for the TD Clip. This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).

Submitted by Zephyr Sleep Technologies, Inc. (Calgary, CA). The FDA issued a Cleared decision on June 7, 2019, 147 days after receiving the submission on January 11, 2019.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.

Submission Details

510(k) Number K190051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2019
Decision Date June 07, 2019
Days to Decision 147 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 158d · This submission: 147d
Pathway characteristics
Standards-based clearance path.

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 19
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K190051.
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