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

Pad, Neonatal Eye

21 CFR 880.5270 / General Hospital
FDA source (opens on fda.gov)

FOK is the FDA product code for Pad, Neonatal Eye, a class I device type, regulated under 21 CFR 880.5270. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FOK
Device name
Pad, Neonatal Eye
Regulation
21 CFR 880.5270
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code FOK

By decision year
5 clearances under product code FOK with a decision year between 1981 and 1996, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FOK by decision year
YearClearances
19811
19841
19851
19931
19961

Applicants with the most clearances

Product code FOK
Applicants holding the most 510(k) clearances under product code FOK
ApplicantClearances
A & a Medical Supplies Inc.1
Alba Health Care1
Debusk Technology Corp.1
Graphic Controls Corp.1
Montrose Phototherapy Supply1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order