510(k) · Cleared
Recalled · Class I · 2023Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety Software and Supported Syringes (PSS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical MD, Inc. · FRN Pump, Infusion
Cleared on Aug 29, 2011 as substantially equivalent to K040899 (Medex, Inc., 2004) and 3 other predicates after a 103-day review. Its family tree reaches back 3 generations to 1994. 5 of the 16 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 16 times, including 6 Class I recalls.
- Decided
- Aug 29, 2011
- Review
- 103 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 16 (6 Class I)
- Predicates
- 4
Its longest line of descent runs back 3 generations to K940147 (1994). 11 ancestors in all, the oldest K890120 (1989). 4 later devices descend from it, 2 citing it directly. 5 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK940147 Auto Syringe AS40A Infusion PumpBaxter Corp. · 1994 · Recalled
- 2 generations backK974332 Variable Pressure Syringe PumpAlaris Medical Systems, Inc. · 1998
- 1 generation backK023264 Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · Recalled (Class I)
- This deviceK111386 Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2…Smiths Medical MD, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK211125 Novum IQ Syringe PumpBaxter Healthcare Corporation · 2022 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK160482 t:slim Insulin Delivery System, t:flex Insulin Delivery System…Tandem Diabetes Care, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK242390 Novum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation · 2024 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK162080 t:slim Insulin Delivery System, t:flex Insulin Delivery System…Tandem Diabetes Care, Inc. · 2016
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K211125Novum IQ Syringe PumpBaxter Healthcare Corporation · 2022 · cites it directly1descendant
- K160482t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc. · 2016 · cites it directly1descendant
- K242390Novum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation · 2024 · 2 generations on0descendants
- K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940147 | Auto Syringe AS40A Infusion Pump | Baxter Corp. | 1994 | 1 |
| −2 | K974332 | Variable Pressure Syringe Pump | Alaris Medical Systems, Inc. | 1998 | — |
| −1 | K023264 | Medley Syringe Pump Module System, Model 8110 | Alaris Medical Systems, Inc. | 2002 | Class I |
| 0 (this device) | K111386 | Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication… | Smiths Medical MD, Inc. | 2011 | — |
| +1 | K211125 | Novum IQ Syringe Pump | Baxter Healthcare Corporation | 2022 | Class I |
| +1 | K160482 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device… | Tandem Diabetes Care, Inc. | 2016 | — |
| +2 | K242390 | Novum IQ Syringe Pump (40800BAXUS) | Baxter Healthcare Corporation | 2024 | Class I |
| +2 | K162080 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device… | Tandem Diabetes Care, Inc. | 2016 | — |
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 |
|---|---|---|
| 2016 | 2 | 0 |
| 2022 | 1 | 1 |
| 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? (4)
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 |
|---|---|---|---|
| * | K040899 | Medex 3000 Series MR Syringe Infusion PumpSummary page 1…Product Code: FRN, MRZ Regulation: 21 CFR §880.5725 Predicate Device(s) The predicate devices are the currently marketed Medfusion® Model 3500 Syringe Infusion Pump (K040899), PharmGuard® Toolbox (K042432), ALARIS Medical Systems, Inc. Medley ™ Syringe Pump Module (K023264), and the ALARIS Medical Syst… | 2004 |
| * | K042432 | Pharmguard Toolbox, Model G6000782Summary page 1…tion: 21 CFR §880.5725 Predicate Device(s) The predicate devices are the currently marketed Medfusion® Model 3500 Syringe Infusion Pump (K040899), PharmGuard® Toolbox (K042432), ALARIS Medical Systems, Inc. Medley ™ Syringe Pump Module (K023264), and the ALARIS Medical Systems Inc. Medley™ System with Me… | 2005 |
| * | K023264 | Medley Syringe Pump Module System, Model 8110Summary page 1…e the currently marketed Medfusion® Model 3500 Syringe Infusion Pump (K040899), PharmGuard® Toolbox (K042432), ALARIS Medical Systems, Inc. Medley ™ Syringe Pump Module (K023264), and the ALARIS Medical Systems Inc. Medley™ System with Medication Management System (K030459). Device Description The Medfusi… | 2002 |
| * | K030459 | Medley System with Medication Management System (MMS)Summary page 1…box (K042432), ALARIS Medical Systems, Inc. Medley ™ Syringe Pump Module (K023264), and the ALARIS Medical Systems Inc. Medley™ System with Medication Management System (K030459). Device Description The Medfusion® Model 4000 Syringe Infusion Pump software version 1.1 is a wireless capable electro-mechani… | 2003 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2023 | Class I | Z-0864-2024 | Software Design Change | Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. Delivery During Motor Not Running High Priority Alarm (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 2. Re-administered Loading Dose… |
| Dec 19, 2023 | Class II | Z-1541-2024 | 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-1543-2024 | 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-0079-2024 | 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… |
| Oct 10, 2022 | Class II | Z-0272-2023 | Under Investigation by firm | Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation |
| Apr 18, 2022 | Class I | Z-1271-2022 | 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. |
| Oct 28, 2019 | Class I | Z-0610-2020 | Software design | There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm functionality, and interruption of therapy. |
| Oct 15, 2018 | Class II | Z-2554-2019 | Process control | Customers who utilize PharmGuard¿ Server Software (PGS) with Medfusion¿ 4000 pumps manufactured prior to November 10, 2017, may experience wireless network connectivity issues on certain pumps due to a potential Radio Module issue on some… |
| 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-1134-2018 | 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-0313-2018 | 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… |
| Nov 22, 2013 | Class II | Z-0540-2014 | Device Design | Smiths Medical is conducting a recall involving all Medfusion 4000 Syringe Infusion Pumps. Smiths Medical has identified an issue with electrical shorting at the AC power receptacle. Shorting can occur when saline solution or other… |
| Feb 14, 2012 | Class I | Z-2107-2012 | Software design | Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that causes a device history log corruption and triggers a Watchdog Fail-Safe alarm. When the device exhibits this failure mode, visual and… |
The 5 latest of 16 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.
- K040899Medex 3000 Series MR Syringe Infusion PumpMedex, Inc. · 2004 · Direct predicate · ◆ in the 2004 ancestors bar of FIG. 14 Class I recalls
- K023264Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K211125Novum IQ Syringe PumpBaxter Healthcare Corporation · 2022 · Cites it directly · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
- K242390Novum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation · 2024 · 2 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 5 of the 11 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K211125 (Baxter Healthcare Corporation, 2022) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K040899.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 PharmGuard® Supported Syringes is an accessory to the PharmGuard® Toolbox 2 Medication Safety Software that expands the available supported syringes that can be selected when creating user defined configuration parameters using the PharmGuard® Toolbox 2 Medication Safety Software. The Medfusion® Model 4000 Syringe Infusion Pump is indicated for the following uses: In the administration of fluids requiring precisely controlled infusion rates including…
Read the full statement (253 words)
The PharmGuard® Supported Syringes is an accessory to the PharmGuard® Toolbox 2 Medication Safety Software that expands the available supported syringes that can be selected when creating user defined configuration parameters using the PharmGuard® Toolbox 2 Medication Safety Software.
The Medfusion® Model 4000 Syringe Infusion Pump is indicated for the following uses:
In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, Enteral solutions and other therapeutic fluids.
By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral,
By 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.
The PharmGuard® Toolbox 2 Medication Safety Software is indicated to provide a vehicle to create and securely upload user-defined configuration parameters a library of drug names and associated user-defined infusion parameters to Medfusion® Model 4000 Syringe Infusion Pump with software version V1.0 or higher. The PharmGuard® Toolbox 2 Medication Safety Software collects and downloads operational, infusion and alarm history events, library usage counts, and PharmGuard® safety events from the Medfusion® Pump. It is intended to provide a dataset users can collect and analyze to improve overall processes and lessen the likelihood of operator error when entering infusion parameters into the Medfusion® Pump.
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/K111386 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111386: Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety Software and Supported Syringes (PSS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111386
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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