HITClass I

Tester, Color Vision

21 CFR 886.1170 / Ophthalmic

HIT is the FDA product code for Tester, Color Vision, a class I device type, regulated under 21 CFR 886.1170. As of 2026-09-10, FDA records hold 9 510(k) clearances under this code, the most recent dated 1991-06-25, and no recalls.

Classification record

Product code: HIT
Device name: Tester, Color Vision
Regulation: 21 CFR 886.1170
Device class: Class I
Review panel: Ophthalmic
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: Yes
Third party review eligible: No
Ingested clearances: 9
Ingested recalls: 0

Clearances, product code HIT

By decision year

9 clearances under product code HIT with a decision year between 1981 and 1991, 1985 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code HIT by decision year
Year	Clearances
1981	1
1983	1
1984	1
1985	2
1987	2
1988	1
1991	1

Applicants with the most clearances

Product code HIT

Applicants holding the most 510(k) clearances under product code HIT
Applicant	Clearances
Richmond Products, Inc.	2
Carl Zeiss, Inc.	1
Gynopharma, Inc.	1
Keeler Instruments, Inc.	1
LKC Technologies, Inc.	1
Luneau Laboratories	1
Titmus Optical, Inc.	1
Visidyne Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 37 companies shown, in name order