Cleared Traditional

K881011 - BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS

K881011 is an FDA 510(k) clearance for BIVONA ULTRA LOW RESISTANCE VOICE PROST..., 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 64-day FDA review.

K881011 · Bivona Medical Technologies · Ear, Nose, Throat device
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May 1988
Decision
64d
Days
Class 2
Risk

K881011 is an FDA 510(k) clearance for the BIVONA ULTRA LOW RESISTANCE 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 May 13, 1988 after a review of 64 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 - K881011

510(k) Number K881011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1988
Decision Date May 13, 1988
Days to Decision 64 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
26d faster than avg
Panel avg: 90d · This submission: 64d
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 K881011.
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