510(k) · Cleared
Recalled · 2007Medex 3000 Series 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 6, 1999 as substantially equivalent to K890120 (Medfusion, Inc., 1989) and 3 other predicates after a 251-day review. Its family tree reaches back 1 generation to 1989. 7 of the 28 devices in its family, counting itself, have a Class I recall. 23 later devices descend from it. It has been recalled once.
- Decided
- Apr 6, 1999
- Review
- 251 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 1 generation to K890120 (1989). 4 ancestors in all. 23 later devices descend from it, 2 citing it directly. 7 of the 28 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK890120 Syringe Infusion PumpMedfusion, Inc. · 1989
- This deviceK982640 Medex 3000 Series Syringe Infusion PumpMedex, Inc. · 1999
- Descendant · cites it directly · 21 of its ownK023264 Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · Recalled (Class I)
- Descendant · 2 generations on · 6 of its ownK053554 CompufloMilestone Scientific, Inc. · 2006
- Descendant · 3 generations on · 5 of its ownK101194 Navigator Delivery System (or Navigator DS) Model: Nav-010Carticept Medical, Inc. · 2011
- Descendant · 4 generations on · 4 of its ownK112067 Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2011
- Descendant · 2 generations on · 4 of its ownK111386 Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2…Smiths Medical MD, Inc. · 2011 · Recalled (Class I)
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 23 · See all- K023264Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · cites it directly21descendants
- K053554CompufloMilestone Scientific, Inc. · 2006 · 2 generations on6descendants
- K101194Navigator Delivery System (or Navigator DS) Model: Nav-010Carticept Medical, Inc. · 2011 · 3 generations on5descendants
- K112067Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2011 · 4 generations on4descendants
- K111386Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety…Smiths Medical MD, Inc. · 2011 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890120 | Syringe Infusion Pump | Medfusion, Inc. | 1989 | — |
| 0 (this device) | K982640 | Medex 3000 Series Syringe Infusion Pump | Medex, Inc. | 1999 | — |
| +1 | K023264 | Medley Syringe Pump Module System, Model 8110 | Alaris Medical Systems, Inc. | 2002 | Class I |
| +2 | K053554 | Compuflo | Milestone Scientific, Inc. | 2006 | — |
| +3 | K101194 | Navigator Delivery System (or Navigator DS) Model: Nav-010 | Carticept Medical, Inc. | 2011 | — |
| +4 | K112067 | Navigator Delivery System (Navigator DS) | Carticept Medical, Inc. | 2011 | — |
| +2 | K111386 | Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication… | Smiths Medical MD, Inc. | 2011 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 1 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 1 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 1 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 1 |
| 2022 | 2 | 1 |
| 2023 | 1 | 1 |
| 2024 | 1 | 1 |
| 2025 | 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.
7 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 |
|---|---|---|---|
| * | K890120 | Syringe Infusion PumpSummary page 1…ump, for purposes as defined under Section 510(k) of the Federal Food, Drug and Cosmetic Act, is substantially equivalent to the Medex 2000 Series Syringe Infusion Pumps K890120, K901755 and K955231 and the Baxter AutoSyringe AS50 Infusion Pump K945942 (SE decision 7/10/95). For simplicity, the Medex 2010i… | 1989 |
| * | K901755 | Model 3001 Syringe Infusion PumpSummary page 1…purposes as defined under Section 510(k) of the Federal Food, Drug and Cosmetic Act, is substantially equivalent to the Medex 2000 Series Syringe Infusion Pumps K890120, K901755 and K955231 and the Baxter AutoSyringe AS50 Infusion Pump K945942 (SE decision 7/10/95). For simplicity, the Medex 2010i will be… | 1990 |
| * | K955231 | Medfusion Model 2001 Syringe Infusion PumpSummary page 1…defined under Section 510(k) of the Federal Food, Drug and Cosmetic Act, is substantially equivalent to the Medex 2000 Series Syringe Infusion Pumps K890120, K901755 and K955231 and the Baxter AutoSyringe AS50 Infusion Pump K945942 (SE decision 7/10/95). For simplicity, the Medex 2010i will be used through… | 1996 |
| * | K945942 | Auto Syringe (R) AS50 Infusion PumpSummary page 1…and Cosmetic Act, is substantially equivalent to the Medex 2000 Series Syringe Infusion Pumps K890120, K901755 and K955231 and the Baxter AutoSyringe AS50 Infusion Pump K945942 (SE decision 7/10/95). For simplicity, the Medex 2010i will be used throughout this 510(k) to represent the Medex 2000 Series Syr… | 1995 |
What descends from it? (23)
See all 232 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (7 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 3, 2007 | Not classified | Z-0768-2007 | Other | Software anomaly that causes the pump to experience a sudden and unexpected failure. This anomaly occurs during the pump's startup sequence when the pump's Preventative Maintenance Alarm goes off, preventing the pump from completing its… |
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.
- K023264Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
- K133532Alaris System with Guardrails Suite MXCarefusion 303, Inc. · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 128 Class I recalls
- K111386Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety Software and Supported…Smiths Medical MD, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 16 Class I recalls
- K191910SpaceStation MRIB. Braun Melsugen AG · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls
- K211125Novum IQ Syringe PumpBaxter Healthcare Corporation · 2022 · 3 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
- K211218BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc. · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 17 Class I recalls
- K242390Novum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation · 2024 · 4 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
Nearest 5 of 7; all are on the web page.
What does this lineage say?
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 Syringe Infusion Pump indications for use are as follows: ¢ in the administration of fluids requiring precisely controlled infusion rates including blood or bfood products, lipids, drugs, antibiotics and other therapeutic fluids. ¢ in the following delivery routes: arterial, epidural, intravenous, spinal, and subcutaneous. ¢ in the following delivery modes: continuous, volume/time, mass, body weight, custom dilution, intermittent…
Read the full statement (118 words)
The Medex 3000 Series Syringe Infusion Pump indications for use are as follows:
¢ in the administration of fluids requiring precisely controlled infusion rates including blood or bfood products, lipids, drugs, antibiotics and other therapeutic fluids.
¢ in the following delivery routes: arterial, epidural, intravenous, spinal, and subcutaneous.
¢ 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.
¢ the Syringe Infusion Pump is contraindicated for use on the inlet side of extracorporeal membrane oxygenation (ECMO) systems where high negative pressures may occur.
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/K982640 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982640: Medex 3000 Series Syringe Infusion Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982640
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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