# DEN150001: Relizorb

- Pathway: De Novo (Direct)
- Applicant: Alcresta, Inc.
- Decided: Nov 20, 2015 after 322 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
No predicates in its family tree.
7 later devices descend from it; 3 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)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K161247: Relizorb (2016), 6 descendants of its own
- 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

## Indications for use
indicated for use in adults to hydrolyze fats in enteral formula.

Source page: https://510kreport.com/device/DEN150001
Methodology: https://510kreport.com/methodology