# K191379: RELiZORB

- Pathway: 510(k) (Traditional)
- Applicant: Alcresta Therapeutics, Inc.
- Decided: Dec 4, 2019 after 195 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: 3 generations back to DEN150001 (2015). 3 ancestors in all.
4 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)
- DEN150001: Relizorb, Alcresta, Inc. (2015) Summary page 4.
- K161247: Relizorb, Alcresta Therapeutics, Inc. (2016) Summary page 4.
- K163057: Relizorb, Alcresta Therapeutics, Inc. (2017) Summary page 4.

## Most influential descendants
- K231156: Enzyme Packed Cartridge - RELiZORB (2023), 3 descendants of its own
- K232784: RELiZORB® (2023), 2 descendants of its own
- 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 5 years and above) and adult patients to hydrolyze fats in enteral formula.

Source page: https://510kreport.com/device/K191379
Methodology: https://510kreport.com/methodology