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

Tonometer, Manual

21 CFR 886.1930 / Ophthalmic
FDA source (opens on fda.gov)

HKY is the FDA product code for Tonometer, Manual, a class II device type, regulated under 21 CFR 886.1930. As of , FDA records hold 56 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
HKY
Device name
Tonometer, Manual
Regulation
21 CFR 886.1930
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
56
Ingested recalls
2

Clearances, product code HKY

By decision year
56 clearances under product code HKY with a decision year between 1977 and 2024, 2000 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code HKY by decision year
YearClearances
19771
19781
19821
19831
19841
19851
19861
19881
19921
19931
19952
19963
19971
19991
20004
20011
20021
20033
20041
20061
20072
20081
20101
20131
20143
20152
20163
20172
20183
20191
20202
20211
20222
20231
20243

Applicants with the most clearances

Product code HKY
Applicants holding the most 510(k) clearances under product code HKY
ApplicantClearances
Icare Finland Oy7
Keeler Ltd.4
Cats Tonometer, LLC3
Cso2
Falck Medical Corporation2
Oculab, Inc.2
Reichert, Inc.2
Takagi Seiko Co., Ltd.2
Accutome, Inc.1
Automated Ophthalmics Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 59 companies shown, in name order