# K070268: Signature Edition Infusion System, Models 710X, 720X

- Pathway: 510(k) (Special)
- Applicant: Cardinal Health 303,Inc.
- Decided: Feb 23, 2007 after 25 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: 1 generation back to K931549 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931549: Model EZ-1 Sing Chan/EZ-2 Dual Channel Infus Pump, Y (1993) Summary page 1.

## Indications for use
The Signature Edition® Infusion System (Models 71OX and 720X) is 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® Infusion System is 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/K070268
Methodology: https://510kreport.com/methodology