Cleared Special

K043138 - PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134

K043138 is an FDA 510(k) clearance for PROVOX NID VOICE REHABILITATION SYSTEM, manufactured by Atos Medical AB. The device is a Class 2 Ear, Nose, Throat device with product code EWL cleared through the Special 510(k) pathway after a 10-day FDA review.

K043138 · Atos Medical AB · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
10d
Days
Class 2
Risk

K043138 is an FDA 510(k) clearance for the PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134. Classified as Prosthesis, Laryngeal (taub) (product code EWL), Class II - Special Controls.

Submitted by Atos Medical AB (Horby, SE). The FDA issued a Cleared decision on November 22, 2004 after a review of 10 days - a notably fast clearance cycle.

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. 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.

FDA 510(k) Submission Details - K043138

510(k) Number K043138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2004
Decision Date November 22, 2004
Days to Decision 10 days
Submission Type Special
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
80d faster than avg
Panel avg: 90d · This submission: 10d
Pathway characteristics
Modification to existing cleared device.

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 33
Devices cleared under the same product code (EWL) and FDA review panel - the closest regulatory comparables to K043138.
BLOM-SINGER INDWELLING TEP OCCLUDER
K093258 · Helix Medical, LLC · Mar 2010
PROVOX VEGA, MODEL 8130-8135
K090455 · Atos Medical AB · Jun 2009
BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES
K082206 · Helix Medical, LLC · Sep 2008
PROVOX FREEHANDS HME, MODEL 7710
K022125 · Atos Medical AB · Jul 2002
BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS
K991587 · Helix Medical, Inc. · Jun 1999
VOICE MASTER PROSTHESIS
K974132 · E. Benson Hood Lab, Inc. · Feb 1998