# K231804: PRIME-XV FreezIS DMSO-Free MD

- Pathway: 510(k) (Abbreviated)
- Applicant: Fujifilm Irvine Scientific
- Decided: Nov 9, 2023 after 142 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: 3 generations back to DEN000008 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
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 5.
- K201789: CT-Stor, Energy Delivery Solutions (2021) Summary page 5.

## Indications for use
PRIME-XV FreezlS DMSO-Free MD is for use in human ex vivo tissue and cell culture processing applications.

Source page: https://510kreport.com/device/K231804
Methodology: https://510kreport.com/methodology