# K091308: Alaris PC Unit, Models 8000 and 8015

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health 303,Inc.
- Decided: Jul 9, 2009 after 66 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 K950419 (1995). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
4 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051641: Alaris System PC Unit, Model 8001, Cardinal Health, Alaris Products (2005)

## Most influential descendants
- K133532: Alaris System with Guardrails Suite MX (2014), 3 descendants of its own
- K211218: BD Alaris System with Guardrails Suite MX v12.1.2 (2023), 1 descendant of its own
- K243855: BD Alaris Infusion System with Guardrails Suite MX (2025), 0 descendants of its own
- K210074: Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable (2022), 0 descendants of its own
- K110535: Alaris PC Unit Module 8000 with Software Correction (2012), 0 descendants of its own

## 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 TM 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/K091308
Methodology: https://510kreport.com/methodology