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)
Top companies in KOC
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2026 | Fresenius Medical Care Renal Therapies Group, LLC 5008X HD/HDF with Twister Blood
Tubing Set
Part Number 03-5350-8 Open, Classified |
KOC | K243505 |
| Sep 2, 2026 | Fresenius Medical Care Renal Therapies Group, LLC 5008X HD/HDF with CLiC Blood
Tubing Set
Part number 03-5300-3C Open, Classified |
KOC | K243505 |
| Sep 2, 2026 | Fresenius Medical Care Renal Therapies Group, LLC 5008X HD/HDF Standard Blood
Tubing Set
Part Number 03-5300-3 Open, Classified |
KOC | K243505 |
| Sep 2, 2026 | Fresenius Medical Care Renal Therapies Group, LLC 5008X Standard HD Pre-Flush
Standard Blood Tubing Set
Part Number 03-5110-6 Open, Classified |
KOC | K243505 |
| Sep 6, 2018 | Stihler 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 |
KOC | K082758 |
| Sep 6, 2018 | Stihler 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 |
KOC | K082758 |
| Sep 6, 2018 | Stihler 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 |
KOC | K082758 |
| Mar 24, 2017 | Molded Products Inc Non-Sterile Double DIN to DIN "Y" Connector,
Product Usage:
Extension for connecting hemodialysis blood tubing to the hemodialyzer. Terminated |
KOC | K003712 |
| May 24, 2016 | Fresenius 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 |
KOC | K121599 |
| Jun 5, 2015 | Fresenius Medical Care Holdings, Inc. CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters
Model: CL10021021 Terminated |
KOC | K935958 |
| Feb 3, 2015 | Fresenius 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 |
KOC | K022536 |
| Mar 18, 2013 | Molded Products Inc Sterile Access & Return Line Set, 36" Length, Part # UM-872-36.
Intended for use with medically prescribed hemodialysis blood tubing. Terminated |
KOC | K003712 |
| Jan 23, 2009 | Fresenius 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 |
KOC | K022536 |
| Jan 23, 2009 | Fresenius 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 |
KOC | K022536 |
| Mar 29, 2006 | Baxter Healthcare Renal Div Baxter BM11 Blood Monitor Pump hemodialysis machine; Baxter Healthcare Corporation, Deerfield, IL 60015; product code 5M3005, 5M3005R Terminated |
KOC | K911315 |
| Jul 20, 2004 | Horizon 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 |
KOC | None listed |
| Jul 20, 2004 | Horizon 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 |
KOC | K941851 |
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