Cleared Traditional

K821568 - BLOW-SINGER TRACHEOSTOMA VALVE

K821568 is an FDA 510(k) clearance for BLOW-SINGER TRACHEOSTOMA VALVE, 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 60-day FDA review.

K821568 · Bivona Medical Technologies · Ear, Nose, Throat device
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Jul 1982
Decision
60d
Days
Class 2
Risk

K821568 is an FDA 510(k) clearance for the BLOW-SINGER TRACHEOSTOMA VALVE. 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 July 26, 1982 after a review of 60 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 - K821568

510(k) Number K821568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1982
Decision Date July 26, 1982
Days to Decision 60 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
30d faster than avg
Panel avg: 90d · This submission: 60d
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 K821568.
DUCKBILL VOICE PROSTHESIS & TRACHEO
K832967 · American V. Mueller · Dec 1983
BLAISE-RATHAEL VOICE PROSTHESIS
K832852 · Richards Medical Co., Inc. · Sep 1983
LOW PRESSURE BLOM-SINGER VOICE PROSTHES
K823749 · Bivona Medical Technologies · Jan 1983
PERISCOPE VOICE PROSTHESIS
K820737 · Bivona Medical Technologies · Apr 1982
SILASTIC VOICE PROSTHESIS
K812864 · Dow Corning Corp. Healthcare Industries Materials · Nov 1981
BLOM-SINGER VOICE PROSTHESIS
K812982 · Bivona Medical Technologies · Nov 1981