Cleared Traditional

ENVOYCEM, MODEL 1640 (K080032) - FDA 510(k) Clearance

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

K080032 · Envoy Medical Corporation · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Feb 2008
Decision
52d
Days
Class 2
Risk

K080032 is an FDA 510(k) clearance for the ENVOYCEM, MODEL 1640. Classified as Cement, Ear, Nose And Throat (product code NEA), Class II - Special Controls.

Submitted by Envoy Medical Corporation (St. Paul, US). The FDA issued a Cleared decision on February 28, 2008 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 872.3275 - 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 Envoy Medical Corporation devices

Submission Details

510(k) Number K080032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2008
Decision Date February 28, 2008
Days to Decision 52 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
37d faster than avg
Panel avg: 89d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NEA Cement, Ear, Nose And Throat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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.