510(k) · Cleared
Recalled · Class I · 2025Novum IQ Large Volume Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corporation · FRN Pump, Infusion
Cleared on Mar 29, 2024 as substantially equivalent to K173084 (Baxter Healthcare Corporation, 2018) after a 1,079-day review. Its family tree reaches back 6 generations to 1990. 6 of the 11 devices in its family, counting itself, have a Class I recall. It has been recalled 3 times, including 3 Class I recalls.
- Decided
- Mar 29, 2024
- Review
- 1,079 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 3 (3 Class I)
- Predicates
- 1
Its longest line of descent runs back 6 generations to K904518 (1990). 10 ancestors in all. No later device cites it as a predicate yet. 6 of the 11 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 5 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- 4 generations backK011975 Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Recalled (Class I)
- 3 generations backK042121 Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · Recalled (Class I)
- 2 generations backK133801 Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · Recalled (Class I)
- 1 generation backK173084 Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2018 · Recalled (Class I)
- This deviceK211122 Novum IQ Large Volume PumpBaxter Healthcare Corporation · 2024
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −5 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| −4 | K011975 | Horizon Outlook with Dosecom | B.Braun Medical, Inc. | 2001 | Class I |
| −3 | K042121 | Spectrum and Spectrum with Master Drug Library | Sigma Intl. | 2004 | Class I |
| −2 | K133801 | Baxter Sigma Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | 2014 | Class I |
| −1 | K173084 | Spectrum IQ Infusion System, Dose IQ Safety Software | Baxter Healthcare Corporation | 2018 | Class I |
| 0 (this device) | K211122 | Novum IQ Large Volume Pump | Baxter Healthcare Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 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.
6 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? (1)
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 5…21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN PREDICATE DEVICE: Spectrum IQ Infusion System with Dose IQ Safety Software (K173084) DESCRIPTION OF THE DEVICE: The Novum IQ Large Volume Pump (LVP) is a large volumetric smart pump within the Novum IQ infusion p… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 4, 2025 | Class I | Z-2332-2025 | Software design (manufacturing process) | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false… |
| Jul 14, 2025 | Class I | Z-2173-2025 | Device Design | Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double. (e.g., rate change… |
| Apr 24, 2025 | Class I | Z-1767-2025 | Device Design | There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded. |
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 · ◆ on the line of descent in FIG. 14 Class I recalls
- K133801Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · 2 generations back · ◆ on the line of descent in FIG. 15 Class I recalls
- K042121Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · 3 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- 7 of the 10 ancestors have a recall of any class; 5 have a Class I recall.
- 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. 2024, 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 Novum IQ Large Volume Pump (LVP) is intended for use on adults and pediatric subpopulations, except for neonates, for the controlled administration of fluids, pharmaceutical drugs, parenteral nutrition, blood and blood products through the following clinically accepted routes of administration: intravenous, arterial, subcutaneous and epidural. The Novum IQ LVP is intended for use on neonates, for the controlled administration of fluids and parenteral…
Read the full statement (182 words)
The Novum IQ Large Volume Pump (LVP) is intended for use on adults and pediatric subpopulations, except for
neonates, for the controlled administration of fluids, pharmaceutical drugs, parenteral nutrition, blood and blood products
through the following clinically accepted routes of administration: intravenous, arterial, subcutaneous and epidural.
The Novum IQ LVP is intended for use on neonates, for the controlled administration of fluids and parenteral nutrition
through the following clinically accepted routes of administration: intravenous and arterial.
The Novum IQ LVP is intended to be used in conjunction with legally marketed and compatible administration sets, and
medications provided by the user.
The Novum IQ LVP is suitable for patient care in hospitals and outpatient health care facilities.
The Novum IQ LVP is intended to aid in the reduction of operator interaction through guided programming, including a
way to automate the programming of infusion parameters and documentation of infusion therapies when integrated with
an Electronic Medical Record (EMR) system. This automation is intended to aid in the reduction of programming errors.
The Novum IQ LVP is intended to be used by trained healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211122 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211122: Novum IQ Large Volume Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211122
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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