510(k) · Cleared
ClearedMedfusion Model 2001 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 Jul 18, 1996 after a 247-day review. The FDA summary names its predicate without a number. 7 of the 25 devices in its family, counting itself, have a Class I recall. 24 later devices descend from it.
- Decided
- Jul 18, 1996
- Review
- 247 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 2 citing it directly. 7 of the 25 devices in this family, counting this one, have a Class I recall.
- This deviceK955231 Medfusion Model 2001 Syringe Infusion PumpMedex, Inc. · 1996
- Descendant · cites it directly · 23 of its ownK982640 Medex 3000 Series Syringe Infusion PumpMedex, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 21 of its ownK023264 Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · Recalled (Class I)
- Descendant · 3 generations on · 6 of its ownK053554 CompufloMilestone Scientific, Inc. · 2006
- Descendant · 4 generations on · 5 of its ownK101194 Navigator Delivery System (or Navigator DS) Model: Nav-010Carticept Medical, Inc. · 2011
- Descendant · 5 generations on · 4 of its ownK112067 Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2011
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 24 · See all- K982640Medex 3000 Series Syringe Infusion PumpMedex, Inc. · 1999 · cites it directly23descendants
- K023264Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · 2 generations on21descendants
- K053554CompufloMilestone Scientific, Inc. · 2006 · 3 generations on6descendants
- K101194Navigator Delivery System (or Navigator DS) Model: Nav-010Carticept Medical, Inc. · 2011 · 4 generations on5descendants
- K112067Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2011 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955231 | Medfusion Model 2001 Syringe Infusion Pump | Medex, Inc. | 1996 | — |
| +1 | K982640 | Medex 3000 Series Syringe Infusion Pump | Medex, Inc. | 1999 | 1 |
| +2 | K023264 | Medley Syringe Pump Module System, Model 8110 | Alaris Medical Systems, Inc. | 2002 | Class I |
| +3 | K053554 | Compuflo | Milestone Scientific, Inc. | 2006 | — |
| +4 | K101194 | Navigator Delivery System (or Navigator DS) Model: Nav-010 | Carticept Medical, Inc. | 2011 | — |
| +5 | K112067 | Navigator Delivery System (Navigator DS) | Carticept Medical, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | — | Medfusion 2001 Named without a submission number | |
| * | — | Medfusion 2010 Named without a submission number | |
| * | — | Medfusion 2010i Named without a submission number |
What descends from it? (24)
See all 242 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)
No FDA recall names this device.
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 · 2 generations on · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
- K133532Alaris System with Guardrails Suite MXCarefusion 303, Inc. · 2014 · 3 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 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 16 Class I recalls
- K191910SpaceStation MRIB. Braun Melsugen AG · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls
- K211125Novum IQ Syringe PumpBaxter Healthcare Corporation · 2022 · 4 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 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 17 Class I recalls
- K242390Novum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation · 2024 · 5 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?
- Of its descendants, K982640 (Medex, Inc., 1999) has gone furthest, with 23 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 intended medical application of Medex Medfusion 2000 Series syringe pumps is to produce controlled movement of the plunger of a syringe to inject a set amount of therapeutic fluid into a patient within a hospital setting at a set rate and at set times.
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/K955231 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955231: Medfusion Model 2001 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/K955231
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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