# K980165: Infutest 2000 Infusion Device Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Datrend Systems, Inc.
- Decided: Apr 20, 1998 after 94 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
Longest line of descent: 2 generations back to K897096 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961862: Models Ida-2 Plus and Ipt-1, Bio-Tek Instruments, Inc. (1997) Summary page 1.
- K897096: Model 404A I.V. Infusion Pump Analyzer, Dynatech/Nevada, Inc. (1990) Summary page 1.

## Indications for use
The Infutest 2000 Infusion Device Analyzer (Infutest) is intended to verify the correct operation of infusion pumps. Infutest is designed to be used by biomedical electronics technicians, third party service personnel, and others who may be charged with the responsibility of determining the functionality of an infusion pump.

Source page: https://510kreport.com/device/K980165
Methodology: https://510kreport.com/methodology