Cleared Traditional

K913230 - UNIDIRECTIONAL OCCLUDER

K913230 is an FDA 510(k) clearance for UNIDIRECTIONAL OCCLUDER, manufactured by Welch Allyn, Inc.. The device is a Class 1 Ophthalmic device with product code HOY cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K913230 · Welch Allyn, Inc. · Ophthalmic device
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Oct 1991
Decision
72d
Days
Class 1
Risk

K913230 is an FDA 510(k) clearance for the UNIDIRECTIONAL OCCLUDER. Classified as Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (product code HOY), Class I - General Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on October 2, 1991 after a review of 72 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.

FDA 510(k) Submission Details - K913230

510(k) Number K913230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1991
Decision Date October 02, 1991
Days to Decision 72 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 110d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

HOY Device Classification - Class 1, General Controls

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 54
Devices cleared under the same product code (HOY) and FDA review panel - the closest regulatory comparables to K913230.
INSTRUMENT WIPE AND CORNEAL SHIELD
K912576 · Katena Products, Inc. · Jan 1992
PEEPERS TANNING GOGGLES
K914095 · California Suncare, Inc. · Oct 1991
EYE BUBBLE
K912367 · Aaron Medical Industries · Oct 1991
OCULAR OCCLUDER
K900942 · Microdynamics · May 1990
OMNIPATCH
K900941 · Eye Garter Company, Inc. · May 1990
SOFT CORNEAL LIGHT SHIELD
K896681 · Visitec Co. · Jan 1990
K913230 · UNIDIRECTIONAL OCCLUDER
Download PDF Welch Allyn, Inc.