# K063288: Signature Edition Gold Infusion System, Model 7X3X

- Pathway: 510(k) (Special)
- Applicant: Cardinal Health 303,Inc.
- Decided: Nov 28, 2006 after 27 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 K931549 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032147: Signature Edition Infusion Pump, Signature Edition Administration Sets, Models 70XX, 71XX, 72XX, 7XXXX Series, Alaris Medical Systems, Inc. (2003) Summary page 1.

## Indications for use
The Signature Edition® Gold Infusion Systems, which are also known as the Alaris® SE Pumps, are intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products. The Signature Edition® Gold Infusion Systems are indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces.

Source page: https://510kreport.com/device/K063288
Methodology: https://510kreport.com/methodology