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

Lens, Contact, Polymethylmethacrylate, Diagnostic

21 CFR 886.1385 / Ophthalmic
FDA source (opens on fda.gov)

HJK is the FDA product code for Lens, Contact, Polymethylmethacrylate, Diagnostic, a class II device type, regulated under 21 CFR 886.1385. As of , FDA records hold 41 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
HJK
Device name
Lens, Contact, Polymethylmethacrylate, Diagnostic
Regulation
21 CFR 886.1385
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
41
Ingested recalls
3

Clearances, product code HJK

By decision year
41 clearances under product code HJK with a decision year between 1979 and 2020, 1986 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code HJK by decision year
YearClearances
19791
19868
19873
19884
19892
19914
19945
19971
20011
20023
20031
20041
20053
20141
20151
20181
20201

Applicants with the most clearances

Product code HJK
Applicants holding the most 510(k) clearances under product code HJK
ApplicantClearances
Ocular Instruments, Inc.25
Volk Optical Inc4
American Medical Devices, Inc.1
Concept, Inc.1
Dutch Ophthalmic Research Center (D.O.R.C.)1
Fci Ophthalmics, Inc.1
Haag-Streit USA Inc1
Insight Instruments, Inc.1
Insight International, Inc.1
Luneau SA1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 25 companies shown, in name order