# K110535: Alaris PC Unit Module 8000 with Software Correction

- Pathway: 510(k) (Traditional)
- Applicant: Carefusion 303, Inc.
- Decided: Mar 26, 2012 after 395 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: 3 generations back to K950419 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
2 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091308: Alaris PC Unit, Models 8000 and 8015, Cardinal Health 303,Inc. (2009)

## Indications for use
The Alaris® PC Unit is the main user interface unit and power supply of the Alaris® System, a modular system to be used with Alaris® System modules (aka Medley™ System modules) intended for use in today's growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices. The specific intended use for each Alaris® System module is specified in its respective submission.

Source page: https://510kreport.com/device/K110535
Methodology: https://510kreport.com/methodology