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

Refractor, Manual, Non-Powered, Including Phoropter

21 CFR 886.1770 / Ophthalmic
FDA source (opens on fda.gov)

HKN is the FDA product code for Refractor, Manual, Non-Powered, Including Phoropter, a class I device type, regulated under 21 CFR 886.1770. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
HKN
Device name
Refractor, Manual, Non-Powered, Including Phoropter
Regulation
21 CFR 886.1770
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
3
Ingested recalls
7

Clearances, product code HKN

By decision year
3 clearances under product code HKN with a decision year between 1979 and 1994, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HKN by decision year
YearClearances
19791
19871
19941

Applicants with the most clearances

Product code HKN
Applicants holding the most 510(k) clearances under product code HKN
ApplicantClearances
American Optical Corp.1
Canon Medical Components U.S.A., Inc.1
Woodlyn, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 62 companies shown, in name order