Cleared Traditional

K802774 - FIBER OPTIC ADAPTER #60-0892

K802774 is an FDA 510(k) clearance for FIBER OPTIC ADAPTER #60-0892, manufactured by Aspen Laboratories, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code EQH cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K802774 · Aspen Laboratories, Inc. · Ear, Nose, Throat device
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Dec 1980
Decision
43d
Days
Class 1
Risk

K802774 is an FDA 510(k) clearance for the FIBER OPTIC ADAPTER #60-0892. 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

FDA 510(k) Submission Details - K802774

510(k) Number K802774 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 89d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

EQH Device Classification - Class 1, General Controls

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.

Regulatory Peers - EQH Source, Carrier, Fiberoptic Light

All 24
Devices cleared under the same product code (EQH) and FDA review panel - the closest regulatory comparables to K802774.
FIBER OPTIC ADAPTER #60-895
K802771 · Aspen Laboratories, Inc. · Dec 1980
FIBER OPTIC ADAPTER #60-0894
K802772 · Aspen Laboratories, Inc. · Dec 1980
FIBER OPTIC LIGHT GUIDE #60-0767
K802773 · Aspen Laboratories, Inc. · Dec 1980
FIBER OPTIC ADAPTER #60-0896
K802775 · Aspen Laboratories, Inc. · Dec 1980
FIBER OPTIC LIGHT SOURCE
K801176 · Aspen Laboratories, Inc. · May 1980
ADAPTER/STANDARD FIBER OPTICS LIGHT
K760653 · Pilling Co. · Dec 1976