# K961486: Ivac Medsystem Iii, Infusion Pump W/Drug Editing Software Kit

- Pathway: 510(k) (Traditional)
- Applicant: Ivac Medical Systems
- Decided: Apr 17, 1998 after 732 days
- Product code: MRZ (Accessories, 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.
17 later devices descend from it; 1 cites it directly.
0 of 18 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) IVAC MedSystem III Infusion Pump: named in the summary without a submission number

## Most influential descendants
- K061110: Glucommander Plus (2006), 16 descendants of its own
- K101344: G+ System (2010), 13 descendants of its own
- K113853: G+ System (2012), 12 descendants of its own
- K132547: Endo Tool Glucose Management System (Egms) (2014), 8 descendants of its own
- K200443: EndoTool IV 1.10 (2020), 3 descendants of its own

## Indications for use
The intended use of the MedSystem III Infusion Pump is to deliver a wide variety of drugs and fluids (e.g., bloods, lipids, saline, dextrose) over a broad range of infusion rates, at high levels of accuracy. IVAC’s policy is to not indicate specific drugs and/or fluids. Specific intended uses include enteral, intravenous, and epidural deliveries. The Drug Editing Software Kit (DESK) allows the user to customize the resident drug list for the Dose Rate Calculator (DRC) feature that is available in the legally marketed MedSystem III Infusion Pump. The current system allows custom changes on a one by one basis. The DESK system allows users to make permanent custom changes to the resident drug list.

Source page: https://510kreport.com/device/K961486
Methodology: https://510kreport.com/methodology