# K973609: Ida-4 and Ipt-MC

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Tek Instruments, Inc.
- Decided: Dec 18, 1997 after 87 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: 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
This IDA-4 or IPT-MC 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. It is not intended to be used as an infusion device calibrator. A wide range of infusion devices can be analyzed including: syringe, drop counting, peristaltic, and volumetric types. Steady and non-steady flow rate pumps can be analyzed. The device is designed to operate using water or saline only. It incorporates an RS232 serial port for computer control/data output and a Centronics type parallel printer port.

Source page: https://510kreport.com/device/K973609
Methodology: https://510kreport.com/methodology