# K232784: RELiZORB®

- Pathway: 510(k) (Traditional)
- Applicant: Alcresta Therapeutics, Inc.
- Decided: Dec 21, 2023 after 101 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: 5 generations back to DEN150001 (2015). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231156: Enzyme Packed Cartridge - RELiZORB, Alcresta Therapeutics, Inc. (2023) Summary page 5.

## Most influential descendants
- K243284: RELiZORB (100300/ 100301) (2025), 1 descendant of its own
- K250499: RELiZORB (100300/100301) (2025), 0 descendants of its own

## Indications for use
RELiZORB® is indicated for use with pediatric (ages 2 years and above) and adult patients to hydrolyze fats in enteral formula.

Source page: https://510kreport.com/device/K232784
Methodology: https://510kreport.com/methodology