Cleared Special

K240919 - Silk Voice (SMI-04)

K240919 is an FDA 510(k) clearance for Silk Voice (SMI-04), manufactured by Sofregen Medical. The device is a Class 2 Ear, Nose, Throat device with product code MIX cleared through the Special 510(k) pathway after a 30-day FDA review.

K240919 · Sofregen Medical · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
30d
Days
Class 2
Risk

K240919 is an FDA 510(k) clearance for the Silk Voice (SMI-04). Classified as System, Vocal Cord Medialization (product code MIX), Class II - Special Controls.

Submitted by Sofregen Medical (Framingham, US). The FDA issued a Cleared decision on May 3, 2024 after a review of 30 days - a notably fast clearance 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sofregen Medical devices

FDA 510(k) Submission Details - K240919

510(k) Number K240919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2024
Decision Date May 03, 2024
Days to Decision 30 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 90d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 16
Devices cleared under the same product code (MIX) and FDA review panel - the closest regulatory comparables to K240919.
Silk Voice
K180631 · Sofregen Medical, Inc. · Nov 2018
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
VOCALIS GEL
K081815 · Cytophil, Inc. · Jan 2009
VOCALIS AND VOCALIS SM
K081816 · Cytophil, Inc. · Jan 2009