Cleared Traditional

K971244 - PROVOX 2 VOICE PROSTHESIS SYSTEM

K971244 is an FDA 510(k) clearance for PROVOX 2 VOICE PROSTHESIS SYSTEM, 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 64-day FDA review.

K971244 · Atos Medical AB · Ear, Nose, Throat device
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Jun 1997
Decision
64d
Days
Class 2
Risk

K971244 is an FDA 510(k) clearance for the PROVOX 2 VOICE PROSTHESIS SYSTEM. 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 6, 1997 after a review of 64 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K971244

510(k) Number K971244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1997
Decision Date June 06, 1997
Days to Decision 64 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 90d · This submission: 64d
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 33
Devices cleared under the same product code (EWL) and FDA review panel - the closest regulatory comparables to K971244.
PROVOX FREEHANDS HME, MODEL 7710
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VOICE MASTER PROSTHESIS
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K940638 · Atos Medical AB · Jun 1994
BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES
K932120 · Helix Medical, Inc. · Apr 1994
BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET
K932163 · Helix Medical, Inc. · Dec 1993