Cleared Traditional

K863474 - KASEY EYE SHIELD

K863474 is the FDA 510(k) clearance for KASEY EYE SHIELD by Kasey Enterprises, Inc.. It is a Class 1 Ophthalmic device (product code HOY) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K863474 · Kasey Enterprises, Inc. · Ophthalmic device
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Sep 1986
Decision
15d
Days
Class 1
Risk

K863474 is an FDA 510(k) clearance for the KASEY EYE SHIELD. Classified as Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (product code HOY), Class I - General Controls.

Submitted by Kasey Enterprises, Inc. (Elkins Park, US). The FDA issued a Cleared decision on September 24, 1986 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4750 - the FDA ophthalmic 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 Kasey Enterprises, Inc. devices

Submission Details

510(k) Number K863474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1986
Decision Date September 24, 1986
Days to Decision 15 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 110d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HOY Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4750
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 - HOY Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)

All 10
Devices cleared under the same product code (HOY) and FDA review panel - the closest regulatory comparables to K863474.
SOFT CORNEAL LIGHT SHIELD
K896681 · Visitec Co. · Jan 1990
HEALTH CARE EYE PROTECTION
K875107 · Surgikos, Inc. · Mar 1988
EYE GARD
K872000 · Treace Medical, Inc. · Jul 1987
HESSBURG LIGHT GUARD
K853035 · Visitec Co. · Dec 1985
STORZ UNIVERSAL EYE SHIELD
K841599 · Storz Instrument Co. · May 1984
NEONATE MASK FOR BABIES
K840444 · Richards Medical Co., Inc. · Mar 1984