# K243284: RELiZORB (100300/ 100301)

- Pathway: 510(k) (Traditional)
- Applicant: Alcresta Therapeutics, Inc.
- Decided: Jan 15, 2025 after 90 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: 6 generations back to DEN150001 (2015). 6 ancestors in all.
1 later device descends 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)
- K232784: RELiZORB®, Alcresta Therapeutics, Inc. (2023) Summary page 5.

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

## Indications for use
RELiZORB is indicated for use in pediatric (ages 1 year and above) and adults patients to hydrolyze fats in enteral formula.

Source page: https://510kreport.com/device/K243284
Methodology: https://510kreport.com/methodology