Cleared Traditional

K940638 - PROVOX(TM) VOICE PROSTHESIS

K940638 is an FDA 510(k) clearance for PROVOX(TM) VOICE PROSTHESIS, manufactured by Atos Medical AB. The device is a Class 2 Ear, Nose, Throat device with product code EWL cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K940638 · Atos Medical AB · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
128d
Days
Class 2
Risk

K940638 is an FDA 510(k) clearance for the PROVOX(TM) VOICE PROSTHESIS. Classified as Prosthesis, Laryngeal (taub) (product code EWL), Class II - Special Controls.

Submitted by Atos Medical AB (Horby, Sweden, SE). The FDA issued a Cleared decision on June 22, 1994 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3730 - 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 Atos Medical AB devices

FDA 510(k) Submission Details - K940638

510(k) Number K940638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1994
Decision Date June 22, 1994
Days to Decision 128 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 89d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EWL Device Classification - Class 2, Special Controls

Product Code EWL Prosthesis, Laryngeal (taub)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3730
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 - EWL Prosthesis, Laryngeal (taub)

All 19
Devices cleared under the same product code (EWL) and FDA review panel - the closest regulatory comparables to K940638.
FirstFit Surgical Kit
K240763 · Freudenberg Medical, LLC · Dec 2024
SINGH SPEECH SYSTEM (SERIES 'SSS')
K912486 · Exmoor Plastics , Ltd. · Sep 1992
BIVONA-COLORADO VOICE PROSTHESIS
K915761 · Bivona Medical Technologies · Jun 1992
BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS
K881011 · Bivona Medical Technologies · May 1988
ESKA-HERRMANN TRACHEOSTOMY VALVE
K871885 · C.R. Bard, Inc. · Jun 1987
BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS
K861088 · Bivona Medical Technologies · Apr 1986