Cleared Traditional

K803256 - EYETECH-VISION SCREENING SYSTEM

K803256 is an FDA 510(k) clearance for EYETECH-VISION SCREENING SYSTEM, manufactured by Eyedex. The device is a Class 1 Ophthalmic device with product code HOX cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K803256 · Eyedex · Ophthalmic device
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Mar 1981
Decision
71d
Days
Class 1
Risk

K803256 is an FDA 510(k) clearance for the EYETECH-VISION SCREENING SYSTEM. Classified as Chart, Visual Acuity (product code HOX), Class I - General Controls.

Submitted by Eyedex (Mchenry, US). The FDA issued a Cleared decision on March 4, 1981 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1150 - 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 - K803256

510(k) Number K803256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1980
Decision Date March 04, 1981
Days to Decision 71 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 110d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

HOX Device Classification - Class 1, General Controls

Product Code HOX Chart, Visual Acuity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1150
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 - HOX Chart, Visual Acuity

All 31
Devices cleared under the same product code (HOX) and FDA review panel - the closest regulatory comparables to K803256.
NIC OPTRONICS CS-2000
K822215 · Nicolet Biomedical Instruments · Aug 1982
MENTOR POTENTIAL ACUITY METER
K821932 · Mentor O & O, Inc. · Aug 1982
EYE CHARTS
K813376 · Abco Dealers, Inc. · Jan 1982
OPHTHALMIC DRESSING TRAY
K790909 · Pent-Cal, Inc. · Aug 1979
BAYLOW VISUAL ACUITY TESTER
K781452 · Codman & Shurtleff, Inc. · Oct 1978
K803256 · EYETECH-VISION SCREENING SYSTEM
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