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

Retinoscope, Battery-Powered

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

HKM is the FDA product code for Retinoscope, Battery-Powered, a class I device type, regulated under 21 CFR 886.1780. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HKM
Device name
Retinoscope, Battery-Powered
Regulation
21 CFR 886.1780
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
7
Ingested recalls
0

Clearances, product code HKM

By decision year
7 clearances under product code HKM with a decision year between 1984 and 1997, 1995 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code HKM by decision year
YearClearances
19841
19955
19971

Applicants with the most clearances

Product code HKM
Applicants holding the most 510(k) clearances under product code HKM
ApplicantClearances
Neitz Instruments Company, Ltd.5
Electro Optical Instruments1
Rudolf Riester GmbH & Co. KG1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order