Cleared Traditional

K853940 - THE GRONINGEN VOICE PROSTHESIS

K853940 is an FDA 510(k) clearance for THE GRONINGEN VOICE PROSTHESIS, manufactured by Hood Laboratories. The device is a Class 2 Ear, Nose, Throat device with product code EWL cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K853940 · Hood Laboratories · Ear, Nose, Throat device
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Dec 1985
Decision
80d
Days
Class 2
Risk

K853940 is an FDA 510(k) clearance for the THE GRONINGEN VOICE PROSTHESIS. Classified as Prosthesis, Laryngeal (taub) (product code EWL), Class II - Special Controls.

Submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on December 13, 1985 after a review of 80 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.

View all Hood Laboratories devices

FDA 510(k) Submission Details - K853940

510(k) Number K853940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1985
Decision Date December 13, 1985
Days to Decision 80 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 90d · This submission: 80d
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 18
Devices cleared under the same product code (EWL) and FDA review panel - the closest regulatory comparables to K853940.
BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS
K861088 · Bivona Medical Technologies · Apr 1986
DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS
K854118 · Dacomed Corp. · Mar 1986
FLEXIBLE GRASPING FORCEPS
K854112 · Hood Laboratories · Mar 1986
BLOM-SINGER LOW PRESSURE VOICE PROSTHES
K842896 · American V. Mueller · Aug 1984
DUCKBILL VOICE PROSTHESIS & TRACHEO
K832967 · American V. Mueller · Dec 1983
BLAISE-RATHAEL VOICE PROSTHESIS
K832852 · Richards Medical Co., Inc. · Sep 1983