Ross Embrace Enteral Pump
by Ross Product Div. Abbott Laboratories
510(k) K031407
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK031407 | Date20 May 2003 | StatusActive |
Recalls
-
- Terminated 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.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LZH
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5725
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Ross Embrace Enteral Pump is a microprocessor-controlled pump that provides accurate, controlled enteral feeding delivery. It is a volumetric pump that uses a specially designed feeding set, which includes a cassette that delivers measured amounts of enteral product. The device is used to control the delivery rate of liquid enteral feeding formulas.
The Ross Embrace Enteral Pump is intended for use in hospitals, long-term care facilities, or homecare settings to deliver standard liquid enteral formulas or reconstituted powdered formulas to adult and pediatric patients requiring long- or short-term enteral nutrition support. The pump has an FDA 510(k) authorization and is classified as a Class 2 device with the regulation number 880.5725.