Cleared Traditional

K904729 - BLOM-SINGER SHOWER GUARD

K904729 is an FDA 510(k) clearance for BLOM-SINGER SHOWER GUARD, 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 134-day FDA review.

K904729 · Helix Medical, Inc. · Ear, Nose, Throat device
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Feb 1991
Decision
134d
Days
Class 2
Risk

K904729 is an FDA 510(k) clearance for the BLOM-SINGER SHOWER GUARD. 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 February 28, 1991 after a review of 134 days - within the typical 510(k) review window.

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 Helix Medical, Inc. devices

FDA 510(k) Submission Details - K904729

510(k) Number K904729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1990
Decision Date February 28, 1991
Days to Decision 134 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
44d slower than avg
Panel avg: 90d · This submission: 134d
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 K904729.
PROVOX 2 VOICE PROSTHESIS SYSTEM
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BIVONA-COLORADO VOICE PROSTHESIS
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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