# K955231: Medfusion Model 2001 Syringe Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Medex, Inc.
- Decided: Jul 18, 1996 after 247 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 2 cite it directly.
7 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medfusion 2001: named in the summary without a submission number
- (no number) Medfusion 2010: named in the summary without a submission number
- (no number) Medfusion 2010i: named in the summary without a submission number

## Most influential descendants
- K982640: Medex 3000 Series Syringe Infusion Pump (1999), 23 descendants of its own
- K023264: Medley Syringe Pump Module System, Model 8110 (2002), 21 descendants of its own
- K053554: Compuflo (2006), 6 descendants of its own
- K101194: Navigator Delivery System (or Navigator DS) Model: Nav-010 (2011), 5 descendants of its own
- K112067: Navigator Delivery System (Navigator DS) (2011), 4 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K955231
Methodology: https://510kreport.com/methodology