Cleared Traditional

K861088 - BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS

K861088 is an FDA 510(k) clearance for BIVONA ECONOMY DUCKBILL 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 12-day FDA review.

K861088 · Bivona Medical Technologies · Ear, Nose, Throat device
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Apr 1986
Decision
12d
Days
Class 2
Risk

K861088 is an FDA 510(k) clearance for the BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS. Classified as Prosthesis, Laryngeal (taub) (product code EWL), Class II - Special Controls.

Submitted by Bivona Medical Technologies (Gary, US). The FDA issued a Cleared decision on April 2, 1986 after a review of 12 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 - K861088

510(k) Number K861088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1986
Decision Date April 02, 1986
Days to Decision 12 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
78d faster than avg
Panel avg: 90d · This submission: 12d
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 K861088.
BIVONA-COLORADO VOICE PROSTHESIS
K915761 · Bivona Medical Technologies · Jun 1992
BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS
K881011 · Bivona Medical Technologies · May 1988
ESKA-HERRMANN TRACHEOSTOMY VALVE
K871885 · C.R. Bard, Inc. · Jun 1987
DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS
K854118 · Dacomed Corp. · Mar 1986
FLEXIBLE GRASPING FORCEPS
K854112 · Hood Laboratories · Mar 1986
THE GRONINGEN VOICE PROSTHESIS
K853940 · Hood Laboratories · Dec 1985