# K211124: Dose IQ Safety Software

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Aug 30, 2022 after 502 days
- Product code: PHC (Infusion Safety Management Software)
- 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: 6 generations back to K904518 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
5 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173084: Spectrum IQ Infusion System, Dose IQ Safety Software, Baxter Healthcare Corporation (2018) Summary page 5.

## Indications for use
Dose IQ Safety Software is intended to be used with the Novum IQ Syringe Pump to support the controlled administration of fluids. Dose IQ Safety Software is intended to allow users to create and maintain drug libraries, including the configuration of pump settings for the Novum IQ Syringe Pump. Dose IQ Safety Software is intended to allow users to establish the facility-defined syringe list, which is a subset of Baxter’s approved compatible syringes, for the Novum IQ Syringe Pump. Dose IQ Safety Software is intended to be used by licensed pharmacists. Dose IQ Safety Software is intended to be used in hospitals and outpatient health care facilities.

Source page: https://510kreport.com/device/K211124
Methodology: https://510kreport.com/methodology