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

Container, Transport, Kidney

21 CFR 876.5880 / Gastroenterology, Urology
FDA source (opens on fda.gov)

KDK is the FDA product code for Container, Transport, Kidney, a class II device type, regulated under 21 CFR 876.5880. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KDK
Device name
Container, Transport, Kidney
Regulation
21 CFR 876.5880
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code KDK

By decision year
3 clearances under product code KDK with a decision year between 1980 and 2006, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KDK by decision year
YearClearances
19801
19921
20061

Applicants with the most clearances

Product code KDK
Applicants holding the most 510(k) clearances under product code KDK
ApplicantClearances
Keithley Development Co.1
Martin Mclane Medical1
Waters Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code KDK.