Cleared Traditional

K180631 - Silk Voice

K180631 is an FDA 510(k) clearance for Silk Voice, manufactured by Sofregen Medical, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code MIX cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K180631 · Sofregen Medical, Inc. · Ear, Nose, Throat device
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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.

View all Sofregen Medical, Inc. devices

FDA 510(k) Submission Details - K180631

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 90d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MIX Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MIX System, Vocal Cord Medialization

All 12
Devices cleared under the same product code (MIX) and FDA review panel - the closest regulatory comparables to K180631.
Silk Voice (SMI-04)
K240919 · Sofregen Medical · May 2024
Renu Gel
K150400 · Cytophil, Inc. · Apr 2015
CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT
K121795 · Cytophil, Inc. · Feb 2013
VF LIQUIGEL
K083783 · Coapt Systems, Inc. · Sep 2009
MODIFICATION TO VF GEL PLUS
K080956 · Coapt Systems, Inc. · Apr 2008
VF GEL PLUS
K071663 · Coapt Systems, Inc. · Feb 2008