510(k) · Cleared
Recalled · Class I · 2026Novum IQ Syringe Pump (40800BAXUS)
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 Sep 5, 2024 as substantially equivalent to K211125 (Baxter Healthcare Corporation, 2022) after a 24-day review. Its family tree reaches back 5 generations to 1994. 5 of the 14 devices in its family, counting itself, have a Class I recall. It has been recalled 5 times, including a Class I recall.
- Decided
- Sep 5, 2024
- Review
- 24 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 5 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 5 generations to K940147 (1994). 13 ancestors in all, the oldest K890120 (1989). No later device cites it as a predicate yet. 5 of the 14 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK940147 Auto Syringe AS40A Infusion PumpBaxter Corp. · 1994 · Recalled
- 4 generations backK974332 Variable Pressure Syringe PumpAlaris Medical Systems, Inc. · 1998
- 3 generations backK023264 Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · Recalled (Class I)
- 2 generations backK111386 Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2…Smiths Medical MD, Inc. · 2011 · Recalled (Class I)
- 1 generation backK211125 Novum IQ Syringe PumpBaxter Healthcare Corporation · 2022 · Recalled (Class I)
- This deviceK242390 Novum IQ Syringe Pump (40800BAXUS)Baxter 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 |
|---|---|---|---|---|---|
| −5 | K940147 | Auto Syringe AS40A Infusion Pump | Baxter Corp. | 1994 | 1 |
| −4 | K974332 | Variable Pressure Syringe Pump | Alaris Medical Systems, Inc. | 1998 | — |
| −3 | K023264 | Medley Syringe Pump Module System, Model 8110 | Alaris Medical Systems, Inc. | 2002 | Class I |
| −2 | K111386 | Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication… | Smiths Medical MD, Inc. | 2011 | Class I |
| −1 | K211125 | Novum IQ Syringe Pump | Baxter Healthcare Corporation | 2022 | Class I |
| 0 (this device) | K242390 | Novum IQ Syringe Pump (40800BAXUS) | Baxter Healthcare Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 1 |
| 2005 | 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.
5 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 |
|---|---|---|---|
| * | K211125 | Novum IQ Syringe PumpSummary page 5…fusion 880.5725 FRN, LZH 21 CFR 807.92(a)(3) | Legally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K211125 Novum 1Q Syringe Pump FRN Device Description Summary 21 CFR 807.92(a)(4) The Novum IQ Syringe Pump is a general purpose, syring… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 11, 2026 | Class II | Z-3065-2026 | Software design | A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains. |
| Aug 11, 2026 | Class II | Z-3066-2026 | Software design | A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains. |
| Aug 4, 2025 | Class I | Z-2333-2025 | 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… |
| May 12, 2025 | Class II | Z-1964-2025 | Device Design | Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove Syringe" screen when an… |
| Mar 3, 2025 | Class II | Z-1423-2025 | Process control | Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a… |
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.
- K211125Novum IQ Syringe PumpBaxter Healthcare Corporation · 2022 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K111386Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety Software and Supported…Smiths Medical MD, Inc. · 2011 · 2 generations back · ◆ on the line of descent in FIG. 16 Class I recalls
- K040899Medex 3000 Series MR Syringe Infusion PumpMedex, Inc. · 2004 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 14 Class I recalls
- K023264Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- 7 of the 13 ancestors have a recall of any class; 4 have a Class I recall.
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 I1Q Syringe Pump is intended to be used for the controlled administration of fluids. These include pharmaceutical drugs, parenteral nutrition, blood and blood products, and enteral nutrition. The Novum 1Q Syringe Pump is intended to deliver an infusion through the following clinically accepted routes of administration: intravenous, arterial, enteral and subcutaneous. The Novum 1Q Syringe Pump is intended to be used in conjunction with legally…
Read the full statement (178 words)
The Novum I1Q Syringe Pump is intended to be used for the controlled administration of fluids. These include
pharmaceutical drugs, parenteral nutrition, blood and blood products, and enteral nutrition.
The Novum 1Q Syringe Pump is intended to deliver an infusion through the following clinically accepted routes of
administration: intravenous, arterial, enteral and subcutaneous.
The Novum 1Q Syringe Pump is intended to be used in conjunction with legally marketed and compatible administration
sets, syringes, and medications provided by the user.
The Novum I1Q Syringe Pump is suitable for patient care in hospitals and outpatient health care facilities.
The Novum 1Q Syringe Pump is intended for use on adults, pediatrics and neonates.
The Novum I1Q Syringe Pump 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 1Q Syringe Pump is intended to be used by trained healthcare professionals.
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/K242390 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242390: Novum IQ Syringe Pump (40800BAXUS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242390
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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