Cleared Traditional

K854118 - DACOMED CORP. ESKA-HERRMAN VOICE PROSTH...

K854118 is the FDA 510(k) clearance for DACOMED CORP. ESKA-HERRMAN VOICE PROSTH... by Dacomed Corp.. It is a Class 2 Ear, Nose, Throat device (product code EWL) cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K854118 · Dacomed Corp. · Ear, Nose, Throat device
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Mar 1986
Decision
159d
Days
Class 2
Risk

K854118 is an FDA 510(k) clearance for the DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS. Classified as Prosthesis, Laryngeal (taub) (product code EWL), Class II - Special Controls.

Submitted by Dacomed Corp. (Minneapolis, US). The FDA issued a Cleared decision on March 17, 1986 after a review of 159 days - an extended review 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: 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 Dacomed Corp. devices

Submission Details

510(k) Number K854118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1985
Decision Date March 17, 1986
Days to Decision 159 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 89d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 16
Devices cleared under the same product code (EWL) and FDA review panel - the closest regulatory comparables to K854118.
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
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