510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
KPYClass I

Shield, Protective, Personnel

21 CFR 892.6500 / Radiology
FDA source (opens on fda.gov)

KPY is the FDA product code for Shield, Protective, Personnel, a class I device type, regulated under 21 CFR 892.6500. As of , FDA records hold 25 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
KPY
Device name
Shield, Protective, Personnel
Regulation
21 CFR 892.6500
Device class
Class I
Review panel
Radiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
25
Ingested recalls
2

Clearances, product code KPY

By decision year
25 clearances under product code KPY with a decision year between 1978 and 2011, 1995 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code KPY by decision year
YearClearances
19781
19793
19801
19813
19841
19871
19892
19901
19923
19931
19941
19955
19961
20111

Applicants with the most clearances

Product code KPY
Applicants holding the most 510(k) clearances under product code KPY
ApplicantClearances
Davis Lead Aprons, Inc.3
Infab, LLC.2
Medtec LLC2
Moti Enterprises, Inc.2
Pinnacle Distributors, Inc.2
Aukland Medical Plastics, Inc.1
Bloxr Corporation1
Cis-Us, Inc.1
E.I. Dupont de Nemours & Co., Inc.1
F. Walter Hanel GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 185 companies shown, in name order