Cleared Traditional

K932120 - BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES

K932120 is an FDA 510(k) clearance for BLOM-SINGER INDWELLING LOW PRESSURE VOI..., manufactured by Helix Medical, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWL cleared through the Traditional 510(k) pathway after a 347-day FDA review.

K932120 · Helix Medical, Inc. · Ear, Nose, Throat device
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Apr 1994
Decision
347d
Days
Class 2
Risk

K932120 is an FDA 510(k) clearance for the BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES. Classified as Prosthesis, Laryngeal (taub) (product code EWL), Class II - Special Controls.

Submitted by Helix Medical, Inc. (Santa Barbera, US). The FDA issued a Cleared decision on April 15, 1994 after a review of 347 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Helix Medical, Inc. devices

FDA 510(k) Submission Details - K932120

510(k) Number K932120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1993
Decision Date April 15, 1994
Days to Decision 347 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
257d slower than avg
Panel avg: 90d · This submission: 347d
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 24
Devices cleared under the same product code (EWL) and FDA review panel - the closest regulatory comparables to K932120.
BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS
K991587 · Helix Medical, Inc. · Jun 1999
VOICE MASTER PROSTHESIS
K974132 · E. Benson Hood Lab, Inc. · Feb 1998
PROVOX 2 VOICE PROSTHESIS SYSTEM
K971244 · Atos Medical AB · Jun 1997
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