Atlas FDA

Ivenix Infusion System (IIS)

FDA 510(k) clearance K183311 · decided 2019-06-07

Clearance details

K-number
K183311
Device name
Ivenix Infusion System (IIS)
Applicant
Ivenix, Inc.
Decision
Substantially Equivalent
Date received
2018-11-29
Decision date
2019-06-07
Days to decision
190 days
Clearance type
Traditional
Product code
FRN
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
North Andover, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. recall (Z-2223-2026)Fresenius Kabi USA, LLC2026-06-03
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 recall (Z-2224-2026)Fresenius Kabi USA, LLC2026-05-29
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004. recall (Z-2274-2026)Fresenius Kabi USA, LLC2026-05-29
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005. recall (Z-1048-2026)Fresenius Kabi USA, LLC2026-01-12
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled admini recall (Z-0885-2026)Fresenius Kabi USA, LLC2025-12-16
IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Fr recall (Z-0586-2026)Fresenius Kabi USA, LLC2025-12-03
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. recall (Z-0848-2026)Fresenius Kabi USA, LLC2025-12-01
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. recall (Z-0378-2026)Fresenius Kabi USA, LLC2025-10-28
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25) recall (Z-2232-2025)Fresenius Kabi USA, LLC2025-08-01
LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20 recall (Z-2233-2025)Fresenius Kabi USA, LLC2025-08-01
LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021 recall (Z-2234-2025)Fresenius Kabi USA, LLC2025-08-01
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qt recall (Z-2235-2025)Fresenius Kabi USA, LLC2025-08-01
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-S recall (Z-1869-2025)Fresenius Kabi USA, LLC2025-06-06
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital an recall (Z-1019-2025)Fresenius Kabi USA, LLC2025-02-04
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 recall (Z-0763-2025)Fresenius Kabi USA, LLC2025-01-08
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. recall (Z-3153-2024)Fresenius Kabi USA, LLC2024-09-26
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25) recall (Z-2721-2024)Fresenius Kabi USA, LLC2024-09-04
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. recall (Z-1484-2024)Fresenius Kabi USA, LLC2024-04-11
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 recall (Z-1282-2024)Fresenius Kabi USA, LLC2024-03-11
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004 recall (Z-1283-2024)Fresenius Kabi USA, LLC2024-03-11
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004 recall (Z-0549-2024)Fresenius Kabi USA, LLC2023-12-20
Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Numbe recall (Z-2635-2023)Fresenius Kabi USA, LLC2023-09-25
Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004 recall (Z-1313-2023)Fresenius Kabi USA, LLC2023-04-18
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0 recall (Z-0002-2023)Fresenius Kabi USA, LLC2022-10-06