Data / Medical devices / United States / Fenwal, Inc.
Fenwal, Inc.: FDA-registered device maker in Lake Zurich, IL, United States, 29 510(k) clearances
Fenwal, Inc. is registered with the FDA (registration 3004548776) in Lake Zurich, IL, United States. It lists 26 device types. The FDA files 29 510(k) clearances under its listings, the newest dated June 16, 2023. 6 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004548776
- Address
- 3 Corporate DR Ste 300, Lake Zurich, IL, United States, 60047
- Owner or operator
- Fresenius Kabi AG (9027285)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- June 1, 1999
- Registered through
- 2026
- Brand names listed
- 20D NON-VENTED, 2 NEEDLEFREE VALVES, 20D NON-VENTED, 3 NEEDLEFREE VALVES, 20D NON-VENTED, BCV, 2 NEEDLEFREE, 20D NON-VENTED, BCV, 3 NEEDLEFREE VALVES, 20D NON-VENTED, INLINE BCV, NEEDLEFREE, 20D NON-VENTED, NEEDLEFREE VALVE, 288 IN. EXT. SET W/FEMALE/MALE LUER, 3 IN. EXTEN, 1.2 MICRON AE FILTER and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 16, 2023 | K221121 | Volumat Polyethylene I.V. Administration Set | FPA | Substantially Equivalent | Fresenius Kabi | accessdata.fda.gov |
| June 2, 2023 | K220301 | Volumat Line | FPA | Substantially Equivalent | Fresenius Kabi | accessdata.fda.gov |
| June 1, 2022 | K212445 | freeflex+ Transfer Adapter | LHI | Substantially Equivalent | Fresenius Kabi AG | accessdata.fda.gov |
| November 10, 2021 | K213089 | Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector | FPA | Substantially Equivalent | Ivenix, Inc. | accessdata.fda.gov |
| February 11, 2021 | K210089 | CATSmart, Automated Blood Processing Autotransfusion System | CAC | Substantially Equivalent | Fresenius Kabi AG | accessdata.fda.gov |
| September 11, 2020 | K200530 | AMICUS Separator System | GKT | Substantially Equivalent | Fresenius Kabi AG | accessdata.fda.gov |
| November 13, 2019 | K192150 | AMICUS Separator System | LKN | Substantially Equivalent | Fresenius Kabi AG | accessdata.fda.gov |
| September 27, 2019 | K192368 | CATSmart | CAC | Substantially Equivalent | Fresenius Kabi AG | accessdata.fda.gov |
| June 7, 2019 | K183311 | Ivenix Infusion System (IIS) | FRN | Substantially Equivalent | Ivenix, Inc. | accessdata.fda.gov |
| December 10, 2018 | K180831 | CATSmart | CAC | Substantially Equivalent | Fresenius Kabi AG | accessdata.fda.gov |
| December 4, 2018 | K180615 | AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter | LKN | Substantially Equivalent | Fresenius Kabi USA,Llc | accessdata.fda.gov |
| June 15, 2017 | K162826 | Encore Neutral | FPA | Substantially Equivalent | Rymed Technologies, LLC | accessdata.fda.gov |
| November 23, 2016 | K162462 | AMICUS Separator System, AMICUS Separator System; Refurbished | GKT | Substantially Equivalent | Fresenius Kabi USA,Llc | accessdata.fda.gov |
| September 16, 2016 | K160735 | CATSmart | CAC | Substantially Equivalent | Fresenius Kabi AG | accessdata.fda.gov |
| June 10, 2014 | K141019 | AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED | LKN | Substantially Equivalent | Fenwal, Inc. | accessdata.fda.gov |
| May 1, 2013 | K121613 | AGILIA INFUSION SYSTEM | FRN | Substantially Equivalent | Fresenius Kabi AG | accessdata.fda.gov |
| March 22, 2012 | K111702 | AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE | LKN | Substantially Equivalent | Fenwal, Inc. | accessdata.fda.gov |
| March 3, 2008 | K073339 | BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR | BRZ | Substantially Equivalent | Fenwal, Inc. | accessdata.fda.gov |
| September 5, 2006 | K060734 | FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE) | LKN | Substantially Equivalent | Fresenius Medical Care North America | accessdata.fda.gov |
| October 21, 2004 | K042693 | IV ADMINISTRATION SET B400 SP | FPA | Substantially Equivalent | Codan US Corp. | accessdata.fda.gov |
| September 7, 2000 | K001872 | I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411 | FPA | Substantially Equivalent | Codan US Corp. | accessdata.fda.gov |
| June 29, 1999 | K984586 | FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS | DTN | Substantially Equivalent | Fresenius Hemotechnology, Inc. | accessdata.fda.gov |
| February 1, 1999 | K984233 | C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINE | CAC | Substantially Equivalent | Fresenius Hemotechnology, Inc. | accessdata.fda.gov |
| June 13, 1997 | K971274 | C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SET | CAC | Substantially Equivalent | Fresenius AG | accessdata.fda.gov |
| July 31, 1996 | K961706 | P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR | LKN | Substantially Equivalent | Fresenius USA, Inc. | accessdata.fda.gov |
| July 31, 1996 | K960006 | C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM | CAC | Substantially Equivalent | Fresenius AG | accessdata.fda.gov |
| October 26, 1990 | K904223 | SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS | CAK | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| November 6, 1987 | K871198 | BONE MARROW COLLECTION KIT AND STAND | LWE | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| April 28, 1983 | K830755 | I.V. SETS WALRUS BRAND VARIOUS CONFIGUR- | FPA | Substantially Equivalent | Medical Parameters, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 14, 2023 | 91704 | Class II | Ongoing | Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform | Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator. | accessdata.fda.gov |
| February 25, 2021 | 87407 | Class II | Terminated | Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells. | Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood leak at the boot, elbow, or in the channel on the separation chamber of the centrifuge pack. | accessdata.fda.gov |
| June 24, 2019 | 83138 | Class I | Terminated | VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment | The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and 1.1 of Vigilant DrugLib | accessdata.fda.gov |
| March 5, 2019 | 82395 | Class II | Terminated | Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set, 9108504 ATF 120 Fast Start Kit, and 9108494 ATF 40 Fast Start Ki | Based on internal investigations, Fresenius Kabi has identified a multifaceted set of events involving the CATSmart Systems, including the device, software, and disposable which may result in the centrifuge tubing line making contact with the washing chamber. The contact may result in excessive wear of the centrifuge tubing or in extreme cases a puncture of | accessdata.fda.gov |
| February 11, 2019 | 82194 | Class II | Terminated | Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected intraoperatively and postoperatively to obtain washed packed red blood cells | The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use. | accessdata.fda.gov |
| May 24, 2013 | 65296 | Class II | Terminated | AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path. | Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339, Amicus Exchange Kits. Fenwal identified a labeling issue with this batch of Product Code R4R2339 (which was cleared for European use only) in which this batch was distributed within the United States market. The problem is identified as labeling that did not in | accessdata.fda.gov |
Compare with other makers
- All makers of Container, Empty, For Collection & Processing Of Blood & Blood Components
- All makers of Set, Transfer (Blood/Plasma)
- All makers of Pump, Infusion
- All makers of Separator, Automated, Blood Cell, Diagnostic
- All makers of Apparatus, Autotransfusion
- All makers of Bone Marrow Collection/Transfusion Kit
Updated June 16, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.