# K250499: RELiZORB (100300/100301)

- Pathway: 510(k) (Traditional)
- Applicant: Alcresta Therapeutics, Inc.
- Decided: Apr 17, 2025 after 56 days
- Product code: PLQ (Enzyme Packed Cartridge)
- Device class: 2
- Regulation: 21 CFR 876.5985
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to DEN150001 (2015). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243284: RELiZORB (100300/ 100301), Alcresta Therapeutics, Inc. (2025) Summary page 5.

## Indications for use
RELiIZORB is indicated for use in pediatric (including neonates and infants) and adult patients to hydrolyze fats during enteral feeding.

Source page: https://510kreport.com/device/K250499
Methodology: https://510kreport.com/methodology