Cleared Traditional

K932163 - BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET

K932163 is an FDA 510(k) clearance for BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET, 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 225-day FDA review.

K932163 · Helix Medical, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1993
Decision
225d
Days
Class 2
Risk

K932163 is an FDA 510(k) clearance for the BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET. 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 December 15, 1993 after a review of 225 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.

FDA 510(k) Submission Details - K932163

510(k) Number K932163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1993
Decision Date December 15, 1993
Days to Decision 225 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 90d · This submission: 225d
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 K932163.
INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE
K945288 · 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 LOW PRESSURE VOICE PROSTHESIS,P.I.D.S.
K930105 · Helix Medical, Inc. · May 1993
BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET
K920090 · Helix Medical, Inc. · Sep 1992
SINGH SPEECH SYSTEM (SERIES 'SSS')
K912486 · Exmoor Plastics , Ltd. · Sep 1992
K932163 · BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET
Download PDF FDA Summary Helix Medical, Inc.