# K031407: Ross Embrace Enteral Pump

- Pathway: 510(k) (Special)
- Applicant: Ross Product Div. Abbott Laboratories
- Decided: May 20, 2003 after 15 days
- Product code: LZH (Pump, Infusion, Enteral)
- 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jun 21, 2007 · Not classified · Z-1141-2007: Continued use of the pump may cause the door pivot point on the back of the pump to crack or break. This will cause the pump to shut down and stop the initiation of enteral feeding.

## Indications for use
The Ross Embrace Enteral Pump is intended to control the delivery rate of liquid enteral feeding formulas to adult and pediatric patients requiring long- or short-term enteral nutrition support in hospitals, long term care facilities or homecare settings. The device is intended to deliver standard liquid enteral formulas or reconstituted powdered formulas that have been thoroughly mixed into solution. This device is not labeled or intended for parenteral use.

Source page: https://510kreport.com/device/K031407
Methodology: https://510kreport.com/methodology