# K021702: Cryobag, Model CB

- Pathway: 510(k) (Traditional)
- Applicant: Origen Biomedical, Inc.
- Decided: Aug 6, 2002 after 75 days
- Product code: LPZ (Container, Frozen Donor Tissue Storage)
- Device class: U
- 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 K915471 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915471: Cryobag, Janus Biomedical, Inc. (1994) Summary page 1.

## Indications for use
The OriGen tissue storage bags are indicated for use in protecting, storing and freezing cells and tissues.

Source page: https://510kreport.com/device/K021702
Methodology: https://510kreport.com/methodology