# K042432: Pharmguard Toolbox, Model G6000782

- Pathway: 510(k) (Traditional)
- Applicant: Medex, Inc.
- Decided: Jan 4, 2005 after 118 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.
5 later devices descend from it; 1 cites it directly.
3 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K111386: Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety Software and Supported Syringes (PSS) (2011), 4 descendants of its own
- K211125: Novum IQ Syringe Pump (2022), 1 descendant of its own
- K160482: t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater (2016), 1 descendant of its own
- K242390: Novum IQ Syringe Pump (40800BAXUS) (2024), 0 descendants of its own
- K162080: t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater (2016), 0 descendants of its own

## Indications for use
PharmGuard Toolbox is intended to provide a vehicle to create and securely upload user-defined configuration parameters, a library of drug names and associated user-defined infusion parameters to Medex Infusion Pumps. The PharmGuard Toolbox collects and downloads operational, infusion, and alarm history events, library usage counts, and PharmGuard safety events from compatible Medex Infusion Pumps. It is intended to provide a rich dataset users can collect and analyze to improve overall processes and lessen the likelihood of operator error when entering infusion parameters into the Medex Infusion Pumps.

Source page: https://510kreport.com/device/K042432
Methodology: https://510kreport.com/methodology