# K011587: Sentinel Enteral Feeding Pump, LH2001 Enteral Feeding Pump

- Pathway: 510(k) (Traditional)
- Applicant: Entracon Corp.
- Decided: Jun 1, 2001 after 9 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 K852965 (1985). 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)
- K852965: Enteral Feeding Pump, Empire Industries, Inc. (1985) Summary page 1.
- K940555: Sandoz Nutrition Compat Enteral Feed Pump W/Hydration, Sandoz Nutrition (1995) Summary page 1.

## Most influential descendants
- K220230: AMSure Enteral Feeding Pump (2022), 0 descendants of its own

## Indications for use
The enteral feeding pump accurately controls the flow of liquid feeding solution to patients who are unable or unwilling to cohsume adequate nutrients. Liquid feedings may consist of commercially prepared formulas or blenderized foods and are most often delivered by means of nasogastric, nasoduodenal of nasojenjunal feeding tubes. In some cases a surgically placed esophagostomy, gastrostomy or enterostomy tube may be used. The pump is not intended for use with blood or blood products. The pump is not for intravenous delivery.

Source page: https://510kreport.com/device/K011587
Methodology: https://510kreport.com/methodology