Cleared Traditional

LARYNGEAL AUGMENTATION IMPLANT (K033398) - FDA 510(k) Clearance

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

K033398 · Bioform, Inc. · Ear, Nose, Throat device
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Dec 2003
Decision
49d
Days
Class 2
Risk

K033398 is an FDA 510(k) clearance for the LARYNGEAL AUGMENTATION IMPLANT. Classified as System, Vocal Cord Medialization (product code MIX), Class II - Special Controls.

Submitted by Bioform, Inc. (San Mateo, US). The FDA issued a Cleared decision on December 12, 2003 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3620 - 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 Bioform, Inc. devices

Submission Details

510(k) Number K033398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2003
Decision Date December 12, 2003
Days to Decision 49 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 89d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MIX System, Vocal Cord Medialization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3620
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 - MIX System, Vocal Cord Medialization

Devices cleared under the same product code (MIX) and FDA review panel - the closest regulatory comparables to K033398.
Silk Voice (SMI-04)
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K011554 · Biomet, Inc. · Jun 2001
VOCOM SILICONE SYSTEM
K001466 · Smith & Nephew, Inc. · Jul 2000
VOCOM IMPLANT- 8MM
K000533 · Smith & Nephew, Inc. · Mar 2000