Cleared Traditional

K820737 - PERISCOPE VOICE PROSTHESIS (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K820737 · Bivona Medical Technologies · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 89d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.