Cleared Traditional

K820737 - PERISCOPE VOICE PROSTHESIS

K820737 is an FDA 510(k) clearance for PERISCOPE 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 22-day FDA review.

K820737 · Bivona Medical Technologies · Ear, Nose, Throat device
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Apr 1982
Decision
22d
Days
Class 2
Risk

K820737 is an FDA 510(k) clearance for the PERISCOPE VOICE PROSTHESIS. Classified as Prosthesis, Laryngeal (taub) (product code EWL), Class II - Special Controls.

Submitted by Bivona Medical Technologies (Walker, US). The FDA issued a Cleared decision on April 9, 1982 after a review of 22 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 - K820737

510(k) Number K820737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1982
Decision Date April 09, 1982
Days to Decision 22 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
68d faster than avg
Panel avg: 90d · This submission: 22d
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 K820737.
BLAISE-RATHAEL VOICE PROSTHESIS
K832852 · Richards Medical Co., Inc. · Sep 1983
LOW PRESSURE BLOM-SINGER VOICE PROSTHES
K823749 · Bivona Medical Technologies · Jan 1983
BLOW-SINGER TRACHEOSTOMA VALVE
K821568 · Bivona Medical Technologies · Jul 1982
SILASTIC VOICE PROSTHESIS
K812864 · Dow Corning Corp. Healthcare Industries Materials · Nov 1981
BLOM-SINGER VOICE PROSTHESIS
K812982 · Bivona Medical Technologies · Nov 1981
PANJE VOICE PROSTHESIS
K810020 · Xomed, Inc. · Feb 1981