Cleared Traditional

ETA (K883853) - FDA 510(k) Clearance

K883853 · Sevrain-Tech, Inc. · Ear, Nose, Throat device
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Nov 1988
Decision
65d
Days
-
Risk

K883853 is an FDA 510(k) clearance for the ETA. Classified as Hearing Aid, Tactile (product code LRA).

Submitted by Sevrain-Tech, Inc. (Madison, US). The FDA issued a Cleared decision on November 17, 1988 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel. 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 Sevrain-Tech, Inc. devices

Submission Details

510(k) Number K883853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1988
Decision Date November 17, 1988
Days to Decision 65 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 89d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRA Hearing Aid, Tactile
Device Class -