# K931549: Model EZ-1 Sing Chan/EZ-2 Dual Channel Infus Pump

- Pathway: 510(k) (Traditional)
- Applicant: Y
- Decided: Oct 12, 1993 after 197 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
No predicates in its family tree.
3 later devices descend from it; 2 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032147: Signature Edition Infusion Pump, Signature Edition Administration Sets, Models 70XX, 71XX, 72XX, 7XXXX Series (2003), 1 descendant of its own
- K070268: Signature Edition Infusion System, Models 710X, 720X (2007), 0 descendants of its own
- 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.

Source page: https://510kreport.com/device/K931549
Methodology: https://510kreport.com/methodology
