Cleared Traditional

K802766 - FIBER OPTIC ADAPTER CAT#60-0898 (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K802766 · Aspen Laboratories, Inc. · Ear, Nose, Throat device
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Dec 1980
Decision
43d
Days
Class 1
Risk

K802766 is an FDA 510(k) clearance for the FIBER OPTIC ADAPTER CAT#60-0898. Classified as Source, Carrier, Fiberoptic Light (product code EQH), Class I - General Controls.

Submitted by Aspen Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 16, 1980 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4350 - 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 Aspen Laboratories, Inc. devices

Submission Details

510(k) Number K802766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1980
Decision Date December 16, 1980
Days to Decision 43 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
46d faster than avg
Panel avg: 89d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EQH Source, Carrier, Fiberoptic Light
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4350
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.