Cleared Traditional

K180631 - Silk Voice (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180631 · Sofregen Medical, Inc. · Ear, Nose, Throat device
Nov 2018
Decision
244d
Days
Class 2
Risk

K180631 is an FDA 510(k) clearance for the Silk Voice. Classified as System, Vocal Cord Medialization (product code MIX), Class II - Special Controls.

Submitted by Sofregen Medical, Inc. (Medford, US). The FDA issued a Cleared decision on November 8, 2018 after a review of 244 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3620 - the FDA ear, nose and throat device 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K180631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2018
Decision Date November 08, 2018
Days to Decision 244 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 158d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MIX System, Vocal Cord Medialization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3620
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 Ear, Nose, Throat devices follow this clearance model.