Ivenix Infusion System
Large Volume Pump (LVP) Software (order 1 per pump), version 5.0.0
5manufacturers in China registered for this device type
7catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Zyno Electric & Machinery Ltd, Shanghai | Shanghai | Shanghai | Contract manufacturer | 1 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Record
| Listed by | Fresenius Kabi AB, Sweden |
|---|---|
| FDA product code | FRN |
| Device type | Pump, Infusion |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| 510(k) | K183311 |
| Record published | 2023-08-07 |
| Record revised | 2023-08-21 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Storage | Special storage condition: Provided in the IFU |
| Distribution end date | 2023-07-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 030-0028-07 | In distribution | |
| 030-0028-06 | In distribution | |
| 5.0.0 | In distribution | |
| 030-0028-08 | In distribution | |
| LVP-0004 | In distribution | |
| 3.0.0 | In distribution | |
| 030-0028-06 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Port Access Infusion SET | Sb-Kawasumi Laboratories, Inc. | 76 |
| Cadd | ICU Medical, Inc | 56 |
| Flow Control Tubing | GO Medical Industries PTY. Ltd. | 39 |
| Curlin Administration Set | Zevex, Inc. | 30 |
| ambIT | Summit Medical Products, Inc. | 27 |
| Beeline motIV | Rex Pj Tech LLC | 24 |
| RMS Precision Flow Rate TubingTM | Repro-Med Systems, Inc. | 24 |
| Medfusion | ICU Medical, Inc | 24 |
| Volumat™ Line | Fresenius Kabi AB | 24 |
| Outlook® | B. Braun Medical Inc. | 21 |
| Alaris | CareFusion 303, Inc | 19 |
| Alpha Source Battery | Alpha Source Inc. | 17 |
Showing 12 of 191. All products under Pump, Infusion
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210074 | 2022-03-01 |
| K210073 | 2022-03-01 |
| K121613 | 2013-05-01 |
Recalls Naming This Product
21 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Fresenius Kabi USA, LLC | 510(k) number | 2026-05-06 | Class I | Software design (manufacturing process) | 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 AC mains power. | 32 systems |
| Fresenius Kabi USA, LLC | 510(k) number | 2026-05-06 | Class I | Device Design | 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 devices therefore remained in service. | 18,444 |
| Fresenius Kabi USA, LLC | 510(k) number | 2026-02-04 | Class II | Device Design | Potential for the Cassette Loading Lever to break. | 18,444 installed bases |
| Fresenius Kabi USA, LLC | 510(k) number | 2025-11-21 | Class II | Use error | Emphasizing instructions for LVP duration programming located in the IFU. | 30 units |
| Fresenius Kabi USA, LLC | 510(k) number | 2025-11-14 | Class I | Software design | Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death. | 30 units |
| Fresenius Kabi USA, LLC | 510(k) number | 2025-11-03 | Class I | Process control | Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury. | 483 cases (12,075 eaches) |
| Fresenius Kabi USA, LLC | 510(k) number | 2025-11-03 | Class II | Labeling design | Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set. | 15,862 units |
| Fresenius Kabi USA, LLC | 510(k) number | 2025-09-03 | Class II | Process change control | Potential issue that can cause the device to register “phantom” touches in the lower-left corner of the touchscreen during operation. | 6 units |
| Fresenius Kabi USA, LLC | 510(k) number | 2025-06-24 | Class II | Process design | Potential for external cassette leaks | 19,225 units |
| Fresenius Kabi USA, LLC | 510(k) number | 2025-06-24 | Class II | Process design | Potential for external cassette leaks | 14,280 units |
| Fresenius Kabi USA, LLC | 510(k) number | 2025-06-24 | Class II | Process design | Potential for external cassette leaks | 35,925 units |
| Fresenius Kabi USA, LLC | 510(k) number | 2025-06-24 | Class II | Process design | Potential for external cassette leaks | 348,150 units |
| Fresenius Kabi USA, LLC | 510(k) number | 2025-01-10 | Class I | Software Design Change | 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 time or more. 2. If a secondary infus | 23 systems |
| Fresenius Kabi USA, LLC | 510(k) number | 2024-12-06 | Class I | Process control | Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used. | 1,520 units |
| Fresenius Kabi USA, LLC | 510(k) number | 2024-08-30 | Class I | Software design | 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. | 17 units |
| Fresenius Kabi USA, LLC | 510(k) number | 2024-03-07 | Class I | Software Design Change | Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death. | 17 units |
| Fresenius Kabi USA, LLC | 510(k) number | 2023-11-29 | Class I | Process change control | 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 duration of delay/interruption, the iss | 938 US |
| Fresenius Kabi USA, LLC | 510(k) number | 2023-05-10 | Class II | Software design | 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 sequence. May lead to delay in therapy. 2) | 6 US |
| Fresenius Kabi USA, LLC | 510(k) number | 2023-03-10 | Class I | Process control | 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. | 1,546 units |
| Fresenius Kabi USA, LLC | 510(k) number | 2022-09-16 | Class II | Software design | 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-recoverable (Fail-Stop) Pump Problem alarm. | 3 |
| Fresenius Kabi USA, LLC | 510(k) number | 2022-04-22 | Class II | Device Design | 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 Intermediate Pumping Chamber (IPC) of the administ | 1344 pumps |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.