Cleared Traditional

OSCAR COLOUR VISION TESTER (K832843) - FDA 510(k) Clearance

Class I Ophthalmic device.

K832843 · Keeler Instruments, Inc. · Ophthalmic device
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Jan 1984
Decision
135d
Days
Class 1
Risk

K832843 is an FDA 510(k) clearance for the OSCAR COLOUR VISION TESTER. Classified as Tester, Color Vision (product code HIT), Class I - General Controls.

Submitted by Keeler Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 4, 1984 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1170 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Keeler Instruments, Inc. devices

Submission Details

510(k) Number K832843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1983
Decision Date January 04, 1984
Days to Decision 135 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 110d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HIT Tester, Color Vision
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1170
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.