# K053554: Compuflo

- Pathway: 510(k) (Traditional)
- Applicant: Milestone Scientific, Inc.
- Decided: Jul 10, 2006 after 202 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
Longest line of descent: 3 generations back to K940147 (1994). 10 ancestors in all.
6 later devices descend from it; 1 cites it directly.
2 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050107: Harvard 2 Syringe Pump, Model 2001-001, Harvard Clinical Technology (2005) Summary page 2.
- K023264: Medley Syringe Pump Module System, Model 8110, Alaris Medical Systems, Inc. (2002) Summary page 1.
- K040899: Medex 3000 Series MR Syringe Infusion Pump, Medex, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K120830: Navigator Delivery System (Navigator DS) (2012), 3 descendants of its own
- K122215: Navigator Delivery System (Navigator DS) (2012), 2 descendants of its own
- K124053: Navigator Delivery System (Navigator DS) (2013), 1 descendant of its own

## Indications for use
The CompuFlo is intended for use in delivering medication and other fluids in a controlled manner. The CompuFlo is indicated for use in adults for the continuous or intermittent delivery of medications and other fluids through intravenous, intra-arterial, subcutaneous, epidural and enteral routes.

Source page: https://510kreport.com/device/K053554
Methodology: https://510kreport.com/methodology