510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860174Substantially Equivalent

Gunkel Chromagraph Color Vision Tester

Chromagraphics, Inc., Bethesda MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860174 is the FDA 510(k) clearance record for GUNKEL CHROMAGRAPH COLOR VISION TESTER, a class I device, cleared for Chromagraphics, Inc. on under FDA product code HIW (Anomaloscope). FDA records list one 510(k) clearance for Chromagraphics, Inc. As of , FDA records show no recalls naming K860174.

Clearance record

Decision date
Received
(77 days to decision)
Product code
HIW Anomaloscope
Regulation
21 CFR 886.1070
Device class
Class I
Review panel
Ophthalmic
Applicant
Chromagraphics, Inc. 120 Center Dr., Bethesda MD
Third party review
No

Clearances, product code HIW

Trailing 12 months

FDA records hold no clearances under product code HIW in the trailing twelve months.

FDA records show no clearances under product code HIW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HIW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260