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Panels › Gastroenterology, Urology › Product code KOC · Class 2

Accessories, Blood Circuit, Hemodialysis

Regulation 876.5820

0510(k)s in 12 months (182 all time)
4recalls in 12 months (17 all time)
16recalls that name a 510(k)
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Top companies in KOC

DateFirm and productCodeLinked 510(k)
Sep 2, 2026Fresenius Medical Care Renal Therapies Group, LLC
5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
Open, Classified
KOCK243505
Sep 2, 2026Fresenius Medical Care Renal Therapies Group, LLC
5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
Open, Classified
KOCK243505
Sep 2, 2026Fresenius Medical Care Renal Therapies Group, LLC
5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
Open, Classified
KOCK243505
Sep 2, 2026Fresenius Medical Care Renal Therapies Group, LLC
5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
Open, Classified
KOCK243505
Sep 6, 2018Stihler Electronic Gmbh
Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product Code: PF2-WP2618 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
Terminated
KOCK082758
Sep 6, 2018Stihler Electronic Gmbh
Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP31 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
Terminated
KOCK082758
Sep 6, 2018Stihler Electronic Gmbh
Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
Terminated
KOCK082758
Mar 24, 2017Molded Products Inc
Non-Sterile Double DIN to DIN "Y" Connector, Product Usage: Extension for connecting hemodialysis blood tubing to the hemodialyzer.
Terminated
KOCK003712
May 24, 2016Fresenius Medical Care Renal Therapies Group, LLC
Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysi
Terminated
KOCK121599
Jun 5, 2015Fresenius Medical Care Holdings, Inc.
CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
Terminated
KOCK935958
Feb 3, 2015Fresenius Medical Care Holdings, Inc.
Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for non-invasive hematocrit, oxygen saturation and percent change in blood volume ca
Terminated
KOCK022536
Mar 18, 2013Molded Products Inc
Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.
Terminated
KOCK003712
Jan 23, 2009Fresenius Medical Care North America
CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2794-0 Bonded CombiSets - includes pri
Terminated
KOCK022536
Jan 23, 2009Fresenius Medical Care North America
CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2994-6 24 sets / case CombiSet Bloodl
Terminated
KOCK022536
Mar 29, 2006Baxter Healthcare Renal Div
Baxter BM11 Blood Monitor Pump hemodialysis machine; Baxter Healthcare Corporation, Deerfield, IL 60015; product code 5M3005, 5M3005R
Terminated
KOCK911315
Jul 20, 2004Horizon Medical Products Inc
Circle C Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, DCL-800TEC 12 Fr. x 20.3cm, Manufactured by: Horizon Medical Products, Inc., One Horizon Way, P.O. Box 627, Manche
Terminated
KOCNone listed
Jul 20, 2004Horizon Medical Products Inc
Circle C Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, 12 Fr. x 15.2cm, Sterile, Manufactured by: Horizon Medical Products, Inc., One Horizon Way, P.O. Box 627, Manchest
Terminated
KOCK941851

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