510(k) · Cleared
Recalled · Class I · 2023Medex 3000 Series MR Syringe Infusion Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medex, Inc. · FRN Pump, Infusion
Cleared on Apr 30, 2004 after a 24-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 of the 14 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it. It has been recalled 21 times, including 4 Class I recalls.
- Decided
- Apr 30, 2004
- Review
- 24 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 21 (4 Class I)
- Predicates
- 0
13 later devices descend from it, 3 citing it directly. 4 of the 14 devices in this family, counting this one, have a Class I recall.
- This deviceK040899 Medex 3000 Series MR Syringe Infusion PumpMedex, Inc. · 2004
- Descendant · cites it directly · 6 of its ownK053554 CompufloMilestone Scientific, Inc. · 2006
- Descendant · 2 generations on · 5 of its ownK101194 Navigator Delivery System (or Navigator DS) Model: Nav-010Carticept Medical, Inc. · 2011
- Descendant · 3 generations on · 4 of its ownK112067 Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK111386 Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2…Smiths Medical MD, Inc. · 2011 · Recalled (Class I)
- Descendant · 4 generations on · 3 of its ownK120830 Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2012
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K053554CompufloMilestone Scientific, Inc. · 2006 · cites it directly6descendants
- K101194Navigator Delivery System (or Navigator DS) Model: Nav-010Carticept Medical, Inc. · 2011 · 2 generations on5descendants
- K112067Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2011 · 3 generations on4descendants
- K111386Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety…Smiths Medical MD, Inc. · 2011 · cites it directly4descendants
- K120830Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2012 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040899 | Medex 3000 Series MR Syringe Infusion Pump | Medex, Inc. | 2004 | — |
| +1 | K053554 | Compuflo | Milestone Scientific, Inc. | 2006 | — |
| +2 | K101194 | Navigator Delivery System (or Navigator DS) Model: Nav-010 | Carticept Medical, Inc. | 2011 | — |
| +3 | K112067 | Navigator Delivery System (Navigator DS) | Carticept Medical, Inc. | 2011 | — |
| +1 | K111386 | Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication… | Smiths Medical MD, Inc. | 2011 | Class I |
| +4 | K120830 | Navigator Delivery System (Navigator DS) | Carticept Medical, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 3 | 1 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2022 | 1 | 1 |
| 2024 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
4 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (13)
See all 133 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2023 | Class I | Z-0863-2024 | Software Design Change | Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion Restarted with Incorrect Parameters, 3. Screen Lock, 4. Interruption of… |
| Dec 19, 2023 | Class II | Z-1540-2024 | Process control | Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the… |
| Dec 19, 2023 | Class II | Z-1542-2024 | Process control | Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the… |
| Aug 16, 2023 | Class II | Z-0078-2024 | Under Investigation by firm | A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will… |
| Aug 16, 2023 | Class II | Z-0076-2024 | Under Investigation by firm | A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will… |
| Aug 16, 2023 | Class II | Z-0077-2024 | Under Investigation by firm | A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will… |
| Apr 18, 2022 | Class I | Z-1272-2022 | Device Design | Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) - Infusion Continues… |
| Jun 26, 2020 | Class I | Z-2734-2020 | Software design | Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs. |
| Jun 26, 2020 | Class I | Z-2735-2020 | Software design | Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs. |
| Apr 13, 2018 | Class II | Z-2662-2018 | Process change control | Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or the pump, misidentifying the size of a loaded syringe. |
| Nov 13, 2017 | Class II | Z-1136-2018 | Process change control | Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. The inability of a pump to recognize a syringe (i.e. the size of the syringe is unknown to the pump)… |
| Nov 13, 2017 | Class II | Z-1135-2018 | Process change control | Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. The inability of a pump to recognize a syringe (i.e. the size of the syringe is unknown to the pump)… |
| Aug 22, 2017 | Class II | Z-0314-2018 | Component design/selection | Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate the "Invalid Syringe Size" alarm. |
| Dec 3, 2015 | Class II | Z-0653-2022 | Component change control | There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period. These alarms occur at start up when the pump goes through the self-test. This recall… |
| Jan 2, 2012 | Not classified | Z-1206-2012 | Vendor change control | Pumps rendered inoperable at power up (displaying a blank screen and alarm). |
| Jun 22, 2010 | Not classified | Z-2121-2010 | Software design | Smiths Medical is conducting a correction of Medfusion Syringe Infusion Pumps, Models 3010 and 3010a, with obsolete software versions 2.0.2, 2.0.3, and 2.0.4. Smiths Medical has found that pumps with obsolete software may continue to run… |
| May 14, 2010 | Class II | Z-0996-2013 | Device Design | An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure infusions. |
| Nov 16, 2009 | Not classified | Z-0650-2010 | Device Design | Smiths Medical has become aware of an increased trend in reports of Motor Not Running (MNR) and Motor Rate Error (MRE) alarm message events with certain Medfusion Syringe Infusion Pumps, Models 3010A and 3500 (Pump). MNR/ MRE are high… |
| Nov 16, 2009 | Not classified | Z-0651-2010 | Device Design | Smiths Medical has become aware of an increased trend in reports of Motor Not Running (MNR) and Motor Rate Error (MRE) alarm message events with certain Medfusion Syringe Infusion Pumps, Models 3010A and 3500 (Pump). MNR/ MRE are high… |
| Dec 18, 2008 | Not classified | Z-1019-2009 | Nonconforming Material/Component | Delay in therapy. Keypad issues with Medfusion Syringe Infusion Pump, model numbers 3500-306 and 3500-415 ("Pump") have occurred during implementation or shortly after first being placed into use. These issues can be intermittent, and may… |
| Dec 18, 2008 | Not classified | Z-1018-2009 | Nonconforming Material/Component | Delay in therapy. Keypad issues with Medfusion Syringe Infusion Pump, model numbers 3500-306 and 3500-415 ("Pump") have occurred during implementation or shortly after first being placed into use. These issues can be intermittent, and may… |
The 5 latest of 21 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.
- K111386Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety Software and Supported…Smiths Medical MD, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 16 Class I recalls
- K211125Novum IQ Syringe PumpBaxter Healthcare Corporation · 2022 · 2 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
- K242390Novum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation · 2024 · 3 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K053554 (Milestone Scientific, Inc., 2006) has gone furthest, with 6 descendants of its own.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Medex 3000 Series MRI Syringe Infusion Pump indications for use are as follows: · in the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids. * in the following delivery routes: arterial, epidural, intravenous, spinal, subcutaneous, and enteral. * in the following delivery modes: continuous, volume/time, mass, body weight…
Read the full statement (158 words)
The Medex 3000 Series MRI Syringe Infusion Pump indications for use are as follows:
· in the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
* in the following delivery routes: arterial, epidural, intravenous, spinal, subcutaneous, and enteral.
* in the following delivery modes: continuous, volume/time, mass, body weight, custom dilution, intermittent and bolus.
· in critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the use of the syringe infusion pump can be monitored or supervised by a clinician.
* inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla or less.
The syringe infusion pump is contraindicated for use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than -100mm Hg as the high negative pressures can result in uncontrolled fluid flow.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K040899 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040899: Medex 3000 Series MR Syringe Infusion Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040899
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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