Cleared Traditional

K832843 - OSCAR COLOUR VISION TESTER

K832843 is an FDA 510(k) clearance for OSCAR COLOUR VISION TESTER, manufactured by Keeler Instruments, Inc.. The device is a Class 1 Ophthalmic device with product code HIT cleared through the Traditional 510(k) pathway after a 135-day FDA review.

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

FDA 510(k) Submission Details - K832843

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 110d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

HIT Device Classification - Class 1, General Controls

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.