Atlas FDA

KDL

19 FDA 510(k) clearances · Product code

233 daysmedian time to decision
567 days90th percentile
19clearances measured

FDA profile

Official device name
Set, Perfusion, Kidney, Disposable
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5880
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
1999: 1 · 2006: 3 · 2007: 7 · 2016: 30 · 2017: 10
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
OrganProtex HTK Solution (K241239)Bridge TO Life, Ltd.2025-01-24
PERF-GEN Pulsatile Perfusion Solution (K221386)Institut Georges Lopez2022-06-14
BEL-GEN Cold Storage Solution (K221387)Institut Georges Lopez2022-06-14
Servator M SALF Solution (K211842)S.A.L.F. Spa2021-12-20
Custodiol HTK Solution (K192408)Dr. Franz Kohler Chemie GmbH2020-04-24
Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags (K170150)S.A.L.F. Spa2017-10-20
PERF-GEN PULSATILE PERFUSION SOLUTION (K121736)Waters Medical Systems, LLC2013-08-16
BEL-GEN COLD STORAGE SOLUTION (K121618)Waters Medical Systems, LLC2013-06-14
SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L (K091656)Organ Recovery Systems, Inc.2010-03-11
CUSTODIOL (K043461)Dr. Franz Kohler Chemie GmbH2005-02-28
CUSTODIOL HTK SOLUTION (K020924)Dr. Franz Kohler Chemie GmbH2003-01-06
GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET (K955497)Cobe Renal Care, Inc.1997-09-25
VIASPAN (BELZER UW - CSS) (K944866)The Dupont Merck Pharmaceutical Co.1996-04-22
LABELING CHANGE - VIASPAN(TM) (BELZER UW) (K900492)The DU Pont Co.1990-03-20
MOP CATHETER (K891239)Bivona Medical Technologies1989-11-28
BELZER UW-CSS (K883782)Du Pont Critical Care1989-04-20
EURO-COLLINS SOLUTION SETS (K884609)Fresenius USA, Inc.1989-01-26
H.P. MEDICAL GRADE SILICONE TUBING (K780470)Dow Corning Corp. Healthcare Industries Materials1978-04-27
PERFUSION TUBING SET (K760922)Shiley, Inc.1976-11-19

Track KDL automatically

Every clearance here is in the API, with alerts when new ones post.