# K183311: Ivenix Infusion System (IIS)

- Pathway: 510(k) (Traditional)
- Applicant: Ivenix, Inc.
- Decided: Jun 7, 2019 after 190 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 25 (13 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K011442 (2001). 36 ancestors in all.
1 later device descends from it; 1 cites it directly.
15 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173084: Spectrum IQ Infusion System, Dose IQ Safety Software, Baxter Healthcare Corporation (2018) Summary page 4.
- K161469: Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module, Hospira, Inc. (2017) Summary page 4.

## Most influential descendants
- K213089: Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector (2021), 0 descendants of its own

## Recalls of this device
- May 6, 2026 · Class I · Z-2224-2026: Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the
- May 6, 2026 · Class I · Z-2223-2026: Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to
- Feb 4, 2026 · Class II · Z-2274-2026: Potential for the Cassette Loading Lever to break.
- Nov 21, 2025 · Class II · Z-1048-2026: Emphasizing instructions for LVP duration programming located in the IFU.
- Nov 14, 2025 · Class I · Z-0885-2026: Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
- Nov 3, 2025 · Class I · Z-0586-2026: Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
- Nov 3, 2025 · Class II · Z-0848-2026: Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
- Sep 3, 2025 · Class II · Z-0378-2026: Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
- Jun 24, 2025 · Class II · Z-2232-2025: Potential for external cassette leaks
- Jun 24, 2025 · Class II · Z-2235-2025: Potential for external cassette leaks
- Jun 24, 2025 · Class II · Z-2234-2025: Potential for external cassette leaks
- Jun 24, 2025 · Class II · Z-2233-2025: Potential for external cassette leaks
- May 12, 2025 · Class I · Z-1869-2025: Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.
- Jan 10, 2025 · Class I · Z-1019-2025: Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70
- Dec 6, 2024 · Class I · Z-0763-2025: Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
- Aug 30, 2024 · Class I · Z-3153-2024: The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.
- Aug 1, 2024 · Class I · Z-2721-2024: A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).
- Mar 7, 2024 · Class I · Z-1484-2024: Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
- Nov 29, 2023 · Class I · Z-0549-2024: The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and
- May 10, 2023 · Class II · Z-1283-2024: Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up seq
- Mar 10, 2023 · Class I · Z-1313-2023: Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion.
- Sep 16, 2022 · Class II · Z-1282-2024: Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-reco
- Sep 8, 2022 · Class I · Z-0002-2023: The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen g
- Apr 22, 2022 · Class II · Z-2635-2023: Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermedia
- Apr 22, 2022 · Class II · Z-1381-2022: Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm.

## Indications for use
The Ivenix Infusion System is indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration: intravenous, intra-arterial, epidural, and subcutaneous, to adults, pediatric and neonate patients. Administered fluids may be pharmaceutical drugs, red blood cells, platelets, plasma, and other mixtures required for patient therapy. The Ivenix Large Volume Pump (LVP) is indicated for use only with the Ivenix sterile, single use, disposable administration sets, including: Primary dual inlet, single outlet, 1 Y-site Primary single inlet, single outlet Blood Set, dual inlet, single outlet, 1 Y-site, for administration of red blood cells, platelets and plasma Microbore single inlet, single outlet, for administration of epidural fluids Microbore dual inlet, single outlet, 1 Y-site Infusion Management System (IMS): The IMS provides information to the clinician regarding the use of the Ivenix Large Volume Pump (LVP) by way of a drug library, LVP configurations, and by providing remote information regarding LVP status. It also provides information on pump usage data reports to various functions within an institution.

Source page: https://510kreport.com/device/K183311
Methodology: https://510kreport.com/methodology