Cleared Traditional

K945287 - INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE

K945287 is an FDA 510(k) clearance for INHEALTH BLOM-SINGER INDWELLING VALVED ..., 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 39-day FDA review.

K945287 · Helix Medical, Inc. · Ear, Nose, Throat device
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Dec 1994
Decision
39d
Days
Class 2
Risk

K945287 is an FDA 510(k) clearance for the INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE. Classified as Prosthesis, Laryngeal (taub) (product code EWL), Class II - Special Controls.

Submitted by Helix Medical, Inc. (Carpinteria, US). The FDA issued a Cleared decision on December 9, 1994 after a review of 39 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 Helix Medical, Inc. devices

FDA 510(k) Submission Details - K945287

510(k) Number K945287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1994
Decision Date December 09, 1994
Days to Decision 39 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
51d faster than avg
Panel avg: 90d · This submission: 39d
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 K945287.
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