# K083583: Xpresse Injection System

- Pathway: 510(k) (Traditional)
- Applicant: Nordson Efd
- Decided: Jun 30, 2009 after 208 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- 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 K820164 (1982). 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)
- K820164: Empty Sterile Carpuject, Sterling Drug, Inc. (1982) Summary page 1.
- K063180: Isecure Syringe Cartridge Holder, Hospira, Inc. (2006) Summary page 1.

## Most influential descendants
- K131963: Tautona Injector Device (2013), 0 descendants of its own

## Indications for use
The XPRESSE Assist Device is a syringe assist device intended for use in the administration of sterile materials under aseptic conditions in accordance with the best judgment of the clinician.

Source page: https://510kreport.com/device/K083583
Methodology: https://510kreport.com/methodology