510(k) · Cleared
Recalled · Class I · 2026Ivenix Infusion System (IIS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivenix, Inc. · FRN Pump, Infusion
Cleared on Jun 7, 2019 as substantially equivalent to K173084 (Baxter Healthcare Corporation, 2018) and 1 other predicate after a 190-day review. Its family tree reaches back 7 generations to 2001. 15 of the 38 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 25 times, including 13 Class I recalls.
- Decided
- Jun 7, 2019
- Review
- 190 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 25 (13 Class I)
- Predicates
- 2
Its longest line of descent runs back 7 generations to K011442 (2001). 36 ancestors in all, the oldest K780880 (1978). 1 later device descends from it, 1 citing it directly. 15 of the 38 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK011442 Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · Recalled (Class I)
- 6 generations backK031185 Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play ModuleAbbott Laboratories · 2003 · Recalled
- 5 generations backK042081 Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3…Hospira, Inc. · 2004 · Recalled (Class I)
- 4 generations backK052052 Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3…Hospira, Inc. · 2005 · Recalled (Class I)
- 3 generations backK103224 Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe…Hospira, Inc. · 2011 · Recalled (Class I)
- 2 generations backK141789 Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play…Hospira, Inc. · 2015 · Recalled (Class I)
- 1 generation backK161469 Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play…Hospira, Inc. · 2017 · Recalled (Class I)
- This deviceK183311 Ivenix Infusion System (IIS)Ivenix, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK213089 Ivenix Infusion System, LVP Epidural Administraion Set NRFit ConnectorIvenix, Inc. · 2021
Class I recalls in this family
- K173084 Spectrum IQ Infusion System, Dose IQ Safety…direct predicate · 2018
- K161469 Plum 360(TM) Infusion System with MedNet/ Smart…direct predicate · 2017
- K141789 Plum 360 Infusion System with Hospira Mednet…2 generations back · 2015
- K133801 Baxter Sigma Spectrum Infusion Pump with Master…2 generations back · 2014
Most influential descendants
Showing 1 of 1 · See all- K213089Ivenix Infusion System, LVP Epidural Administraion Set NRFit ConnectorIvenix, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K011442 | Abbott Plum a+Infusion Pump, Model 11971 | Abbott Laboratories | 2001 | Class I |
| −6 | K031185 | Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play Module | Abbott Laboratories | 2003 | 4 |
| −5 | K042081 | Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion… | Hospira, Inc. | 2004 | Class I |
| −4 | K052052 | Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump… | Hospira, Inc. | 2005 | Class I |
| −3 | K103224 | Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe Tubing | Hospira, Inc. | 2011 | Class I |
| −2 | K141789 | Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0… | Hospira, Inc. | 2015 | Class I |
| −1 | K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module | Hospira, Inc. | 2017 | Class I |
| 0 (this device) | K183311 | Ivenix Infusion System (IIS) | Ivenix, Inc. | 2019 | — |
| +1 | K213089 | Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector | Ivenix, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1981 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 1 |
| 2001 | 1 | 1 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 2 |
| 2005 | 2 | 0 |
| 2006 | 3 | 1 |
| 2010 | 2 | 1 |
| 2012 | 1 | 0 |
| 2014 | 1 | 1 |
| 2018 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
15 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K173084 | Spectrum IQ Infusion System, Dose IQ Safety SoftwareSummary page 4…: 21 CFR 880.5725 Product Codes: FRN, PHC, FPA Device Class: Class II Predicate Device: K173084, Baxter SIGMA Spectra Infusion Pump K161469, Hospira Inc. Plum 360 Infusion System Device D… | 2018 |
| * | K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleSummary page 4…FPA Device Class: Class II Predicate Device: K173084, Baxter SIGMA Spectra Infusion Pump K161469, Hospira Inc. Plum 360 Infusion System Device Description The Ivenix Infusion System (IIS) consists of three primary components:… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213089 | Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector | 2021 | 0 |
Has anything in its family been recalled? (15 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 6, 2026 | Class I | Z-2224-2026 | 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… |
| May 6, 2026 | Class I | Z-2223-2026 | 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. |
| Feb 4, 2026 | Class II | Z-2274-2026 | Device Design | Potential for the Cassette Loading Lever to break. |
| Nov 21, 2025 | Class II | Z-1048-2026 | Use error | Emphasizing instructions for LVP duration programming located in the IFU. |
| Nov 14, 2025 | Class I | Z-0885-2026 | Software design | 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 | Process control | 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 | 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. |
| Sep 3, 2025 | Class II | Z-0378-2026 | Process change control | 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 | Process design | Potential for external cassette leaks |
| Jun 24, 2025 | Class II | Z-2235-2025 | Process design | Potential for external cassette leaks |
| Jun 24, 2025 | Class II | Z-2234-2025 | Process design | Potential for external cassette leaks |
| Jun 24, 2025 | Class II | Z-2233-2025 | Process design | Potential for external cassette leaks |
| May 12, 2025 | Class I | Z-1869-2025 | Under Investigation by firm | 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 | 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… |
| Dec 6, 2024 | Class I | Z-0763-2025 | 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. |
| Aug 30, 2024 | Class I | Z-3153-2024 | 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. |
| Aug 1, 2024 | Class I | Z-2721-2024 | Process control | 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 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. |
| Nov 29, 2023 | Class I | Z-0549-2024 | 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… |
| May 10, 2023 | Class II | Z-1283-2024 | 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.… |
| Mar 10, 2023 | Class I | Z-1313-2023 | 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. |
| Sep 16, 2022 | Class II | Z-1282-2024 | 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… |
| Sep 8, 2022 | Class I | Z-0002-2023 | Software design | 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 goes blank it does not indicate an… |
| Apr 22, 2022 | Class II | Z-2635-2023 | 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… |
| Apr 22, 2022 | Class II | Z-1381-2022 | Software design | Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm. |
The 5 latest of 25 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K173084Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2018 · Direct predicate · ◆ in the 2018 ancestors bar of FIG. 14 Class I recalls
- K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. · 2017 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K141789Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for Plum a+ Infusion…Hospira, Inc. · 2015 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K133801Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · 2 generations back · ◆ in the 2014 ancestors bar of FIG. 15 Class I recalls
- K103224Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe TubingHospira, Inc. · 2011 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K101677Hospira Infusion Blood SetsHospira, Inc. · 2010 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 18 Class I recalls
- K042121Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 13 Class I recalls
- K042081Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with Hospira Mednet…Hospira, Inc. · 2004 · 3 generations back · ◆ on the line of descent in FIG. 14 Class I recalls
- K060806Hospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6 Therapy, Model 13086; Pain Management, Model…Hospira, Inc. · 2006 · 4 generations back · ◆ in the 2006 ancestors bar of FIG. 17 Class I recalls
- K052052Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump System, V11.5Hospira, Inc. · 2005 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K041550Hospira Phoenix Infusion System with Hospira Mednet SoftwareAbbott Laboratories · 2004 · 4 generations back · ◆ in the 2004 ancestors bar of FIG. 12 Class I recalls
- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · 4 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
Nearest 12 of 14 shown.
Nearest 5 of 14; all are on the web page.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 27 of the 36 ancestors have a recall of any class; 14 have a Class I recall.
- Of its descendants, K213089 (Ivenix, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K173084.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
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…
Read the full statement (176 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K183311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183311: Ivenix Infusion System (IIS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183311
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026