# K201789: CT-Stor

- Pathway: 510(k) (Traditional)
- Applicant: Energy Delivery Solutions
- Decided: Sep 20, 2021 after 447 days
- Product code: NDS (Media, Culture, Ex Vivo, Tissue And Cell)
- Device class: 2
- Regulation: 21 CFR 876.5885
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN000008 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022086: Aim-V (R) Medium, Model 087-0112, Invitrogen Corporation (2002) Summary page 4.

## Most influential descendants
- K231804: PRIME-XV FreezIS DMSO-Free MD (2023), 0 descendants of its own

## Indications for use
CT-STOR is a liquid culture media intended for ex vivo cell and tissue processing applications

Source page: https://510kreport.com/device/K201789
Methodology: https://510kreport.com/methodology