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
KDNClass II

System, Perfusion, Kidney

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

KDN is the FDA product code for System, Perfusion, Kidney, a class II device type, regulated under 21 CFR 876.5880. As of , FDA records hold 44 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
KDN
Device name
System, Perfusion, 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
44
Ingested recalls
6

Clearances, product code KDN

By decision year
44 clearances under product code KDN with a decision year between 1983 and 2026, 2025 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code KDN by decision year
YearClearances
19831
19841
19871
19911
19972
19992
20022
20031
20041
20082
20092
20101
20121
20142
20151
20161
20182
20192
20202
20213
20221
20232
20242
20255
20263

Applicants with the most clearances

Product code KDN
Applicants holding the most 510(k) clearances under product code KDN
ApplicantClearances
Paragonix Technologies Inc.7
Bridge to Life Ltd5
Preservation Solutions Inc5
Xvivo Perfusion, Inc.4
Organ Recovery Systems, Inc.3
S.A.L.F. SpA3
Traferox Technologies Inc.3
Waters Instruments, Inc.2
Advanced Equipment Development, Inc.1
Alcon Laboratories1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 31 companies shown, in name order