Cleared Traditional

K875026 - ANOMALOSCOPE PLATE TEST - 5 [APT-5]

K875026 is an FDA 510(k) clearance for ANOMALOSCOPE PLATE TEST - 5 [APT-5], manufactured by Lkc Technologies, Inc.. The device is a Class 1 Ophthalmic device with product code HIT cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K875026 · Lkc Technologies, Inc. · Ophthalmic device
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Feb 1988
Decision
60d
Days
Class 1
Risk

K875026 is an FDA 510(k) clearance for the ANOMALOSCOPE PLATE TEST - 5 [APT-5]. Classified as Tester, Color Vision (product code HIT), Class I - General Controls.

Submitted by Lkc Technologies, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on February 5, 1988 after a review of 60 days - a notably fast clearance cycle.

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: 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 - K875026

510(k) Number K875026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1987
Decision Date February 05, 1988
Days to Decision 60 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
50d faster than avg
Panel avg: 110d · This submission: 60d
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.

Regulatory Peers - HIT Tester, Color Vision

All 8
Devices cleared under the same product code (HIT) and FDA review panel - the closest regulatory comparables to K875026.
SLIMCATH (TM)
K903001 · Gynopharma, Inc. · Jun 1991
H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK.
K873908 · Richmond Products, Inc. · Dec 1987
PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15
K873911 · Richmond Products, Inc. · Dec 1987
TITMUS VISION TESTER II
K844694 · Titmus Optical, Inc. · Jan 1985
COLOR VISION TESTERS
K844365 · Luneau Laboratories · Jan 1985
OSCAR COLOUR VISION TESTER
K832843 · Keeler Instruments, Inc. · Jan 1984
K875026 · ANOMALOSCOPE PLATE TEST - 5 [APT-5]
Download PDF Lkc Technologies, Inc.