# K961862: Models Ida-2 Plus and Ipt-1

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Tek Instruments, Inc.
- Decided: Feb 26, 1997 after 288 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: 1 generation back to K897096 (1990). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K897096: Model 404A I.V. Infusion Pump Analyzer, Dynatech/Nevada, Inc. (1990) Summary page 2.
- (no number) Datrends, Model Infutest 2000: named in the summary without a submission number

## Most influential descendants
- K980165: Infutest 2000 Infusion Device Analyzer (1998), 0 descendants of its own
- K973609: Ida-4 and Ipt-MC (1997), 0 descendants of its own

## Indications for use
This device is designed to be used by manufacturers, biomedical engineering departments in hospitals and third party service organizations to verify the accurate performance of infusion devices that operate in the range stated above.

Source page: https://510kreport.com/device/K961862
Methodology: https://510kreport.com/methodology