# K220230: AMSure Enteral Feeding Pump

- Pathway: 510(k) (Traditional)
- Applicant: Amsino International, Inc.
- Decided: Nov 10, 2022 after 287 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: 2 generations back to K852965 (1985). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011587: Sentinel Enteral Feeding Pump, LH2001 Enteral Feeding Pump, Entracon Corp. (2001) Summary page 4.

## Indications for use
The AMSure® Enteral Feeding Pump is intended to work with the disposable enteral feeding sets to deliver nutritional formula to the gastrointestinal system of adult patients who are physically unable to eat and swallow or who are unable to get sufficient nutrition through eating and swallowing. Only intended for adult patients, not for pediatric use. The AMSure® Enteral feeding pump is intended to be used in healthcare facilities by licensed healthcare professional users only. The AMSure® Enteral feeding pump is for use only with Amsino AMSure® feeding sets.

Source page: https://510kreport.com/device/K220230
Methodology: https://510kreport.com/methodology