Cleared Traditional

EARETTE HEARING AID SEARS #8054 (K810379) - FDA 510(k) Clearance

Class I General Hospital device.

K810379 · Oticon Corp. · General Hospital
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Mar 1981
Decision
19d
Days
Class 1
Risk

K810379 is an FDA 510(k) clearance for the EARETTE HEARING AID SEARS #8054. Classified as Binder, Abdominal (product code FSD), Class I - General Controls.

Submitted by Oticon Corp. (Mchenry, US). The FDA issued a Cleared decision on March 4, 1981 after a review of 19 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5160 - the FDA general hospital 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 Oticon Corp. devices

Submission Details

510(k) Number K810379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1981
Decision Date March 04, 1981
Days to Decision 19 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 129d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FSD Binder, Abdominal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5160
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.