KDJ — Set, Administration, For Peritoneal Dialysis, Disposable Class II

FDA Device Classification

Classification Details

Product Code
KDJ
Device Class
Class II
Regulation Number
876.5630
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250404fresenius medical care renal therapies groupstay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter April 3, 2025
K231849baxter healthcareMiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap EMarch 12, 2024
K214016baxter healthcare corporation15L Cycler Drainage BagMarch 18, 2022
K192705baxter healthcareMiniCap Extended Life PD Transfer SetsOctober 25, 2019
K173593fresenius medical care renal therapies groupstay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extMay 21, 2018
K173651fresenius medical care renal therapies groupMultiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain SetFebruary 14, 2018
K173363fresenius medical care renal therapies groupCycler Drain Bag SetJanuary 24, 2018
K151620puracath medicalFirefly Peritoneal Dialysis Connector Disinfection SystemJanuary 20, 2016
K152675baxter healthcareEXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AOctober 29, 2015
K152129baxter healthcare corporationFlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-IodOctober 29, 2015
K124024fresensius medical care north americaAPD LUER-LOCK ADAPTERSeptember 19, 2013
K083542fresenius medical care north americaFRESENIUS STERILE STAY SAFE CAPDecember 29, 2008
K042900k.e.pK.E.P. CONNECTOR AND CLIPNovember 5, 2004
K041792fresenius medical care north americaFRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211September 24, 2004
K031676baxter healthcareHOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C830November 20, 2003
K022412fresenius medical care north americaFRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTORMarch 5, 2003
K974387microwave medical systemsPDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SETSeptember 1, 1999
K972579baxter healthcareHIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT October 1, 1997
K972731klein-baker medicalNEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SETSeptember 29, 1997
K963668medisystemsMEDISYSTEMS PERITONEAL DIALYSIS SETSAugust 15, 1997