Cleared Traditional

K812982 - BLOM-SINGER VOICE PROSTHESIS

K812982 is an FDA 510(k) clearance for BLOM-SINGER VOICE PROSTHESIS, manufactured by Bivona Medical Technologies. 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.

K812982 · Bivona Medical Technologies · Ear, Nose, Throat device
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Nov 1981
Decision
32d
Days
Class 2
Risk

K812982 is an FDA 510(k) clearance for the BLOM-SINGER VOICE PROSTHESIS. Classified as Prosthesis, Laryngeal (taub) (product code EWL), Class II - Special Controls.

Submitted by Bivona Medical Technologies (Mchenry, US). The FDA issued a Cleared decision on November 24, 1981 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.

View all Bivona Medical Technologies devices

FDA 510(k) Submission Details - K812982

510(k) Number K812982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1981
Decision Date November 24, 1981
Days to Decision 32 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
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 18
Devices cleared under the same product code (EWL) and FDA review panel - the closest regulatory comparables to K812982.
BLOW-SINGER TRACHEOSTOMA VALVE
K821568 · Bivona Medical Technologies · Jul 1982
PERISCOPE VOICE PROSTHESIS
K820737 · Bivona Medical Technologies · Apr 1982
SILASTIC VOICE PROSTHESIS
K812864 · Dow Corning Corp. Healthcare Industries Materials · Nov 1981
PANJE VOICE PROSTHESIS
K810020 · Xomed, Inc. · Feb 1981
BLOM-SINGER DUCKBILL VOICE PROSTHESIS
K800563 · Bivona Medical Technologies · Mar 1980