# K161247: Relizorb

- Pathway: 510(k) (Traditional)
- Applicant: Alcresta Therapeutics, Inc.
- Decided: Jun 30, 2016 after 58 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: 1 generation back to DEN150001 (2015). 1 ancestor in all.
6 later devices descend from it; 2 cite 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.

## Most influential descendants
- K163057: Relizorb (2017), 5 descendants of its own
- K191379: RELiZORB (2019), 4 descendants of its own
- 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

## Indications for use
RELiZORB™ is indicated for use in adults to hydrolyze fats in enteral formula

Source page: https://510kreport.com/device/K161247
Methodology: https://510kreport.com/methodology