ClearanceBrief
Panels › Gastroenterology, Urology › Product code KDJ · Class 2

Set, Administration, For Peritoneal Dialysis, Disposable

Regulation 876.5630

0510(k)s in 12 months (113 all time)
0recalls in 12 months (61 all time)
38recalls that name a 510(k)
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Top companies in KDJ

Decided510(k)Device and applicantCode
Apr 3, 2025K250404stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; st
Fresenius Medical Care Renal Therapies Group, LLC
KDJ
Mar 12, 2024K231849MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist
Baxter Healthcare
KDJ
Mar 18, 2022K21401615L Cycler Drainage Bag
Baxter Healthcare Corporation
KDJ
Oct 25, 2019K192705MiniCap Extended Life PD Transfer Sets
Baxter Healthcare
KDJ
May 21, 2018K173593stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•
Fresenius Medical Care Renal Therapies Group, LLC
KDJ
Feb 14, 2018K173651Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
Fresenius Medical Care Renal Therapies Group, LLC
KDJ
Jan 24, 2018K173363Cycler Drain Bag Set
Fresenius Medical Care Renal Therapies Group, LLC
KDJ
Jan 20, 2016K151620Firefly Peritoneal Dialysis Connector Disinfection System
Puracath Medical, Inc.
KDJ
Oct 29, 2015K152675EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADA
Baxter Healthcare
KDJ
Oct 29, 2015K152129FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution
Baxter Healthcare Corporation
KDJ
Sep 19, 2013K124024APD LUER-LOCK ADAPTER
Fresensius Medical Care North America
KDJ
Dec 29, 2008K083542FRESENIUS STERILE STAY SAFE CAP
Fresenius Medical Care North America
KDJ
Nov 5, 2004K042900K.E.P. CONNECTOR AND CLIP
K.E.P., LLC
KDJ
Sep 24, 2004K041792FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211
Fresenius Medical Care North America
KDJ
Nov 20, 2003K031676HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q
Baxter Healthcare Corp
KDJ
Mar 5, 2003K022412FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR
Fresenius Medical Care North America
KDJ
Sep 1, 1999K974387PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE
Microwave Medical Systems, Inc.
KDJ
Oct 1, 1997K972579HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE
Baxter Healthcare Corp
KDJ
Sep 29, 1997K972731NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET
Klein-Baker Medical, Inc.
KDJ
Aug 15, 1997K963668MEDISYSTEMS PERITONEAL DIALYSIS SETS
Medisystems Corp.
KDJ
Aug 6, 1996K961825ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493
Baxter Healthcare Corp
KDJ
Feb 7, 1995K945567QC CAP
Medionics International, Inc., CA
KDJ
Aug 31, 1994K930843RAPID DISCONNECT Y-SET, CAT. NO. 48-7000
National Medical Care, Medical Products Div., Inc.
KDJ
Mar 28, 1994K921818ABBOTT SMART CAP
Abbott Laboratories
KDJ
Feb 22, 1994K925403BAXTER APD 12' EXTENSION LINE
Baxter Healthcare Corp
KDJ
Feb 25, 1993K921052FRESENIUS VARIABLE FILL MONITOR
Fresenius USA, Inc.
KDJ
Sep 21, 1992K920586DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET
National Medical Care, Medical Products Div., Inc.
KDJ
Sep 21, 1992K920029DEXTROLYTE II CAPD TRNSFER SET
National Medical Care, Medical Products Div., Inc.
KDJ
Mar 16, 1992K915628DEXTROLYTE II PERITONEAL DIALYSIS PUMP
National Medical Care, Medical Products Div., Inc.
KDJ
Feb 19, 1992K915304ABBOTT SMART CAP
Abbott Laboratories
KDJ
Jul 24, 1991K912208FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE
Fresenius USA, Inc.
KDJ
Jan 11, 1991K904806CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR
Fresenius USA, Inc.
KDJ
Nov 21, 1990K900295PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES
Microwave Medical Systems, Inc.
KDJ
Nov 20, 1990K90386990/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET
Fresenius/Delmed, Inc.
KDJ
Nov 20, 1990K902526CAPD DISPOSABLE DISCONNECT Y-SET CODE: 5C4481
Baxter Healthcare Corp
KDJ
Aug 14, 1990K902451LONG-LIFE Y-SET CAT. NO. 48-6366-8
National Medical Care, Medical Products Div., Inc.
KDJ
Jul 16, 1990K900106CLOSED DISCONNECT SYSTEM
Delmed, Inc.
KDJ
Mar 23, 1990K895992CATHETER EXTENSION SET CAT. NO. 48-3027-9
National Medical Care, Medical Products Div., Inc.
KDJ
Mar 23, 1990K895792DEXTROLYTE II CAPD TRANSFER SET - NO. 48-4009-6
National Medical Care, Medical Products Div., Inc.
KDJ
Mar 22, 1990K900323PERITONEAL DIALYSIS CYCLER SET
National Medical Care, Medical Products Div., Inc.
KDJ
Mar 22, 1990K900243DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1015-6
National Medical Care, Medical Products Div., Inc.
KDJ
Mar 22, 1990K900242DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1031-3
National Medical Care, Medical Products Div., Inc.
KDJ
Mar 22, 1990K900226DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1001-6
National Medical Care, Medical Products Div., Inc.
KDJ
Mar 22, 1990K900142DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1003-2
National Medical Care, Medical Products Div., Inc.
KDJ
Mar 22, 1990K900141DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1100-6
National Medical Care, Medical Products Div., Inc.
KDJ
Mar 22, 1990K900140DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET W/3
National Medical Care, Medical Products Div., Inc.
KDJ
Mar 22, 1990K900012DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET
National Medical Care, Medical Products Div., Inc.
KDJ
Mar 22, 1990K900008DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET
National Medical Care, Medical Products Div., Inc.
KDJ
Mar 22, 1990K896600DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1
National Medical Care, Medical Products Div., Inc.
KDJ
Mar 22, 1990K896599DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET -(8)
National Medical Care, Medical Products Div., Inc.
KDJ

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