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

Retinoscope, Ac-Powered

21 CFR 886.1780 / Ophthalmic
FDA source (opens on fda.gov)

HKL is the FDA product code for Retinoscope, Ac-Powered, a class II device type, regulated under 21 CFR 886.1780. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HKL
Device name
Retinoscope, Ac-Powered
Regulation
21 CFR 886.1780
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code HKL

By decision year
6 clearances under product code HKL with a decision year between 1980 and 2000, 1995 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HKL by decision year
YearClearances
19801
19811
19891
19952
20001

Applicants with the most clearances

Product code HKL
Applicants holding the most 510(k) clearances under product code HKL
ApplicantClearances
Neitz Instruments Company, Ltd.2
CMT Medical Technologies, Ltd.1
Hagg-Streit Service, Inc.1
Keeler Instruments, Inc.1
Koi, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code