# K011868: Enteral Expres Pump Unit, Enteral Expres Giving Sets

- Pathway: 510(k) (Traditional)
- Applicant: Debio Tech SA
- Decided: Sep 4, 2001 after 82 days
- Product code: LZH (Pump, Infusion, Enteral)
- 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 K945964 (1995). 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)
- K945964: Kangaroo (R) 524 Enteral Feeding Pump and Administration Sets, Sherwood Medical Co. (1995) Summary page 1.

## Indications for use
The Enteral Exprés enteral fluid delivery system is intended to provide delivery of standard enteral nutrition fluids to patients in the hospital and in alternate site care.

Source page: https://510kreport.com/device/K011868
Methodology: https://510kreport.com/methodology