Cleared Traditional

K945288 - INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE

K945288 is an FDA 510(k) clearance for INHEALTH BLOM-SINGER INDWELLING PLUG IN..., 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 32-day FDA review.

K945288 · Helix Medical, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
32d
Days
Class 2
Risk

K945288 is an FDA 510(k) clearance for the INHEALTH BLOM-SINGER INDWELLING PLUG 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 2, 1994 after a review of 32 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.

FDA 510(k) Submission Details - K945288

510(k) Number K945288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1994
Decision Date December 02, 1994
Days to Decision 32 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 90d · This submission: 32d
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 39
Devices cleared under the same product code (EWL) and FDA review panel - the closest regulatory comparables to K945288.
VOICE MASTER PROSTHESIS
K974132 · E. Benson Hood Lab, Inc. · Feb 1998
PROVOX 2 VOICE PROSTHESIS SYSTEM
K971244 · Atos Medical AB · Jun 1997
INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE
K945287 · Helix Medical, Inc. · Dec 1994
PROVOX(TM) VOICE PROSTHESIS
K940638 · Atos Medical AB · Jun 1994
BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES
K932120 · Helix Medical, Inc. · Apr 1994
BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET
K932163 · Helix Medical, Inc. · Dec 1993
K945288 · INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE
Download PDF Helix Medical, Inc.