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

Company510(k)sRecalls
Baxter Healthcare1649
National Medical Care, Medical Products Div., Inc.300
Travenol Laboratories, S.A.120
Fresenius Medical Care Holdings, Inc.010
Abbott Laboratories70
American Medical Products, Inc.70
Delmed, Inc.60
Fresenius Medical Care North America31
Fresenius Medical Care Renal Therapies Group, LLC40
Dravon Medical, Inc.30
DateFirm and productCodeLinked 510(k)
Nov 27, 2024Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4326K; use in Peritoneal Dialysis
Open, Classified		 KDJNone listed
Nov 27, 2024Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K; use in Peritoneal Dialysis
Open, Classified		 KDJNone listed
Nov 27, 2024Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis
Open, Classified		 KDJNone listed
Nov 27, 2024Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis
Open, Classified		 KDJNone listed
Nov 27, 2024Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
Open, Classified		 KDJNone listed
Nov 27, 2024Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
Open, Classified		 KDJNone listed
Nov 27, 2024Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
Open, Classified		 KDJNone listed
Nov 27, 2024Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
Open, Classified		 KDJK192705
Nov 27, 2024Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
Open, Classified		 KDJNone listed
Nov 27, 2024Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
Open, Classified		 KDJNone listed
Nov 27, 2024Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
Open, Classified		 KDJK152675
Nov 20, 2024Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal Dialysis
Open, Classified		 KDJNone listed
Nov 20, 2024Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis
Open, Classified		 KDJNone listed
Nov 20, 2024Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis
Open, Classified		 KDJNone listed
Nov 20, 2024Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
Open, Classified		 KDJNone listed
Nov 20, 2024Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
Open, Classified		 KDJNone listed
Nov 20, 2024Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
Open, Classified		 KDJNone listed
Nov 20, 2024Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
Open, Classified		 KDJK192705
Nov 20, 2024Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
Open, Classified		 KDJNone listed
Nov 20, 2024Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
Open, Classified		 KDJNone listed
Nov 20, 2024Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
Open, Classified		 KDJK152675
Mar 26, 2024Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Catheter Ext. 6 in
Open, Classified		 KDJK022412
K173593
Mar 26, 2024Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Lock Catheter Ext. 18 in
Open, Classified		 KDJK022412
K173593
Mar 26, 2024Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Lock Catheter Ext. 12 in
Open, Classified		 KDJK022412
K173593
Mar 26, 2024Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Lock Adapter 4 in
Open, Classified		 KDJK022412
K173593
Mar 26, 2024Fresenius Medical Care Holdings, Inc.
stay-safe /Safe Lock Catheter Ext. 12 in
Open, Classified		 KDJK022412
K173593
Dec 7, 2023Fresenius Medical Care Holdings, Inc.
Stay Safe Cap
Open, Classified		 KDJK083542
Mar 3, 2023Baxter Healthcare Corporation
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
Open, Classified		 KDJK152129
Apr 21, 2022Baxter Healthcare Corporation
APD Drain Manifold
Terminated		 KDJNone listed
Apr 21, 2022Baxter Healthcare Corporation
3,65 m Extension Set with Luer-lock Connector
Terminated		 KDJNone listed
Apr 21, 2022Baxter Healthcare Corporation
5 Prong Manifold Set (with Luer Connectors)
Terminated		 KDJNone listed
Apr 21, 2022Baxter Healthcare Corporation
Locking Cap for PD Catheter Adapter
Terminated		 KDJNone listed
Apr 21, 2022Baxter Healthcare Corporation
15 Liters Drain Bag
Terminated		 KDJNone listed
Feb 25, 2022Baxter Healthcare Corporation
MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484
Terminated		 KDJNone listed
Jan 7, 2022Baxter Healthcare Corporation
Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484
Open, Classified		 KDJK152675
Jan 7, 2022Baxter Healthcare Corporation
Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code No. T5C4482
Open, Classified		 KDJK152675
Jan 7, 2022Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, REF R5C4484
Open, Classified		 KDJK152675
Jan 7, 2022Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483
Open, Classified		 KDJK152675
Jan 7, 2022Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E
Open, Classified		 KDJK152675
Jan 7, 2022Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482
Open, Classified		 KDJK152675
Jan 7, 2022Baxter Healthcare Corporation
Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de torsion, 5C4482S
Open, Classified		 KDJK152675
Jan 7, 2022Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ
Open, Classified		 KDJK152675
Jan 7, 2022Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483
Open, Classified		 KDJK152675
Jan 7, 2022Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482
Open, Classified		 KDJK152675
Jan 7, 2022Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449
Open, Classified		 KDJK152675
Apr 28, 2021Fresenius Medical Care Holdings, Inc.
050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe Cap is equivalent to that for the Fresenius Stay Safe Cap and is as follows: Indications for Us
Terminated		 KDJK083542
Apr 28, 2021Fresenius Medical Care Holdings, Inc.
The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chron
Terminated		 KDJK173651
Apr 28, 2021Fresenius Medical Care Holdings, Inc.
The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) c
Terminated		 KDJK124024
Apr 28, 2021Fresenius Medical Care Holdings, Inc.
The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment. The Drain Bag Set is used to collect effluent in bags rather
Terminated		 KDJK173363
Nov 10, 2020Baxter Healthcare Corporation
MiniCap Extended Life PD Transfer Set
Terminated		 KDJK192705

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