510(k) · Cleared
Recalled · Class I · 2023Novum IQ Syringe 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 Aug 30, 2022 as substantially equivalent to K111386 (Smiths Medical MD, Inc., 2011) after a 502-day review. Its family tree reaches back 4 generations to 1994. 5 of the 14 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled once, including a Class I recall.
- Decided
- Aug 30, 2022
- Review
- 502 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 4 generations to K940147 (1994). 12 ancestors in all, the oldest K890120 (1989). 1 later device descends from it, 1 citing it directly. 5 of the 14 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK940147 Auto Syringe AS40A Infusion PumpBaxter Corp. · 1994 · Recalled
- 3 generations backK974332 Variable Pressure Syringe PumpAlaris Medical Systems, Inc. · 1998
- 2 generations backK023264 Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · Recalled (Class I)
- 1 generation backK111386 Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2…Smiths Medical MD, Inc. · 2011 · Recalled (Class I)
- This deviceK211125 Novum IQ Syringe PumpBaxter Healthcare Corporation · 2022
- Descendant · cites it directly · 0 of its ownK242390 Novum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation · 2024 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K242390Novum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K940147 | Auto Syringe AS40A Infusion Pump | Baxter Corp. | 1994 | 1 |
| −3 | K974332 | Variable Pressure Syringe Pump | Alaris Medical Systems, Inc. | 1998 | — |
| −2 | K023264 | Medley Syringe Pump Module System, Model 8110 | Alaris Medical Systems, Inc. | 2002 | Class I |
| −1 | K111386 | Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication… | Smiths Medical MD, Inc. | 2011 | Class I |
| 0 (this device) | K211125 | Novum IQ Syringe Pump | Baxter Healthcare Corporation | 2022 | — |
| +1 | K242390 | Novum IQ Syringe Pump (40800BAXUS) | Baxter Healthcare Corporation | 2024 | Class I |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 1 |
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 |
|---|---|---|---|
| * | K111386 | Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety…Summary page 5…Table 2. Predicate Device Device Company Predicate 510(k) Clearance Date Medfusion Model 4000 Smith’s Medical, MD K111386 August 29, 2011 Syringe Pump INC. DESCRIPTION OF THE DEVICE: The Novum IQ Syringe Pump is a gen… | 2011 |
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 |
|---|---|---|---|
| K242390 | Novum IQ Syringe Pump (40800BAXUS) Class I | 2024 | 0 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 13, 2023 | Class I | Z-0151-2024 | Under Investigation by firm | Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump may display an Infusion Complete alarm even though uninfused fluid remains in… |
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.
- K111386Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety Software and Supported…Smiths Medical MD, Inc. · 2011 · Direct predicate · ◆ on the line of descent in FIG. 16 Class I recalls
- K040899Medex 3000 Series MR Syringe Infusion PumpMedex, Inc. · 2004 · 2 generations back · ◆ in the 2004 ancestors bar of FIG. 14 Class I recalls
- K023264Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K242390Novum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation · 2024 · Cites it directly · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 8.7 years on median.
- 6 of the 12 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K242390 (Baxter Healthcare Corporation, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K111386.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 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 IQ Syringe Pump is intended to deliver an infusion through the following clinically accepted routes of administration: intravenous, arterial, enteral and subcutaneous. The Novum IQ Syringe Pump is intended to be used in conjunction with legally…
Read the full statement (178 words)
The Novum IQ 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 IQ Syringe Pump is intended to deliver an infusion through the following clinically accepted routes of administration: intravenous, arterial, enteral and subcutaneous.
The Novum IQ 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 IQ Syringe Pump is suitable for patient care in hospitals and outpatient health care facilities.
The Novum IQ Syringe Pump is intended for use on adults, pediatrics and neonates.
The Novum IQ 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 IQ Syringe Pump is intended to be used by trained healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211125: Novum IQ Syringe Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211125
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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