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
KDLClass II

Set, Perfusion, Kidney, Disposable

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

KDL is the FDA product code for Set, Perfusion, Kidney, Disposable, a class II device type, regulated under 21 CFR 876.5880. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
KDL
Device name
Set, Perfusion, Kidney, Disposable
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
No
Ingested clearances
19
Ingested recalls
4

Clearances, product code KDL

By decision year
19 clearances under product code KDL with a decision year between 1976 and 2025, 1989 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KDL by decision year
YearClearances
19761
19781
19893
19901
19961
19971
20031
20051
20101
20132
20171
20201
20211
20222
20251

Applicants with the most clearances

Product code KDL
Applicants holding the most 510(k) clearances under product code KDL
ApplicantClearances
Dr. Franz Kohler Chemie GmbH3
Institut Georges Lopez2
S.A.L.F. SpA2
Waters Medical Systems LLC2
Bivona Medical Technologies1
Bridge to Life Ltd1
Cobe Renal Care, Inc.1
Dow Corning Corp. Healthcare Industries Materials1
Du Pont Critical Care1
Fresenius USA, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order