# K141193: Medfusion 4000 Pump Device Specific Reports Solfware for Pharmguard Server Version 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Jul 25, 2014 after 78 days
- Product code: PHC (Infusion Safety Management Software)
- 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K111386: Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety Software and Supported Syringes (PSS), Smiths Medical MD, Inc. (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
Device Specific Reports provide the user information compiled from data generated by networked devices and stored in the PharmGuard Server. This information may be used to support continuous quality improvement programs. Reports generated from the data can be used to analyze and trend various aspects of the designated infusion pump systems and therapies used.

Source page: https://510kreport.com/device/K141193
Methodology: https://510kreport.com/methodology