# K032147: Signature Edition Infusion Pump, Signature Edition Administration Sets, Models 70XX, 71XX, 72XX, 7XXXX Series

- Pathway: 510(k) (Special)
- Applicant: Alaris Medical Systems, Inc.
- Decided: Jul 25, 2003 after 11 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931549 (1993). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 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.
- K931550: EZ Administration Set, Y (1994) Summary page 1.

## Most influential descendants
- K063288: Signature Edition Gold Infusion System, Model 7X3X (2006), 0 descendants of its own

## Recalls of this device
- Aug 10, 2006 · Not classified · Z-1484-06: This recall was initiated because of a potential for over infusion with all models of the Alaris SE Pumps (formerly the Signature Edition Infusion Pumps) caused by key bounce.

## Indications for use
The Signature Edition Infusion System (infusion pumps and administration sets) 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, centeral, or irrigation of fluid spaces.

Source page: https://510kreport.com/device/K032147
Methodology: https://510kreport.com/methodology