FDA.reportPublic FDA data

510(k) K250404

Device
stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch
Applicant
Fresenius Medical Care Renal Therapies Group, LLC
510(k) number
K250404
Product code
KDJ
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-03
Date received
2025-02-12
Regulation
876.5630
Classification name
Set, Administration, For Peritoneal Dialysis, Disposable
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Caitlin Kalda
Address
920 Winter St. Waltham MA US 02451 02451

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KDJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K231849MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483Baxter Healthcare2024-03-12
K21401615L Cycler Drainage BagBaxter Healthcare Corporation2022-03-18
K192705MiniCap Extended Life PD Transfer SetsBaxter Healthcare2019-10-25
K173593stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inchFresenius Medical Care Renal Therapies Group, LLC2018-05-21
K173651Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain SetFresenius Medical Care Renal Therapies Group, LLC2018-02-14
K173363Cycler Drain Bag SetFresenius Medical Care Renal Therapies Group, LLC2018-01-24
K151620Firefly Peritoneal Dialysis Connector Disinfection SystemPuracath Medical, Inc.2016-01-20
K152129FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine SolutionBaxter Healthcare Corporation2015-10-29
K152675EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTERBaxter Healthcare2015-10-29
K124024APD LUER-LOCK ADAPTERFresensius Medical Care North America2013-09-19
K083542FRESENIUS STERILE STAY SAFE CAPFresenius Medical Care North America2008-12-29
K042900K.E.P. CONNECTOR AND CLIPK.E.P., LLC2004-11-05
K041792FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211Fresenius Medical Care North America2004-09-24
K031676HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599QBaxter Healthcare Corp2003-11-20
K022412FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTORFresenius Medical Care North America2003-03-05