510(k) K183311 ยท FRN Pump, Infusion
Ivenix Infusion System (IIS)
| Applicant | Ivenix, Inc., North Andover MA, US |
| Decision | Substantially Equivalent, Jun 7, 2019 |
| Received | Nov 29, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183311
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2026 | Fresenius Kabi USA, LLC LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. Open, Classified |
FRN | None listed |
| May 29, 2026 | Fresenius Kabi USA, LLC The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004. Open, Classified |
FRN | None listed |
| May 29, 2026 | Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 Open, Classified |
FRN | None listed |
| Jan 12, 2026 | Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005. Open, Classified |
FRN | None listed |
| Dec 16, 2025 | Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients. Open, Classified |
FRN | None listed |
| Dec 3, 2025 | Fresenius Kabi USA, LLC IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set. Open, Classified |
FRN | None listed |
| Dec 1, 2025 | Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. Open, Classified |
FRN | None listed |
| Oct 28, 2025 | Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. Open, Classified |
FRN | None listed |
| Aug 1, 2025 | Fresenius Kabi USA, LLC LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25. Open, Classified |
FRN | None listed |
| Aug 1, 2025 | Fresenius Kabi USA, LLC LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20. Open, Classified |
FRN | None listed |
| Aug 1, 2025 | Fresenius Kabi USA, LLC LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25. Open, Classified |
FRN | None listed |
| Aug 1, 2025 | Fresenius Kabi USA, LLC LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25. Open, Classified |
FRN | None listed |
| Jun 6, 2025 | Fresenius Kabi USA, LLC IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set. Open, Classified |
FPA | None listed |
| Feb 4, 2025 | Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), LVP Software LVP-SW-0005.
Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted rou Open, Classified |
FRN | None listed |
| Jan 8, 2025 | Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 Open, Classified |
FRN | None listed |
| Sep 26, 2024 | Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system. Open, Classified |
FRN | None listed |
| Sep 4, 2024 | Fresenius Kabi USA, LLC LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion. Open, Classified |
FPA | None listed |
| Apr 11, 2024 | Fresenius Kabi USA, LLC LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. Open, Classified |
FRN | None listed |
| Mar 11, 2024 | Fresenius Kabi USA, LLC LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 Completed |
FRN | None listed |
| Mar 11, 2024 | Fresenius Kabi USA, LLC LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004 Completed |
FRN | None listed |
| Dec 20, 2023 | Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), Large Volume Pump LVP-0004 Open, Classified |
FRN | None listed |
| Sep 25, 2023 | Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1
Part Number: LVP-SW-0004.
Indicated for use in a hospital and in outpatient care environments for the controlled admin Open, Classified |
FRN | None listed |
| Apr 18, 2023 | Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004 Open, Classified |
FRN | None listed |
| Oct 6, 2022 | Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004
version 5.2.0 Terminated |
PHC | None listed |
| Apr 22, 2022 | Ivenix, Inc. Ivenix Infusion System (IIS) Terminated |
PHC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.