# LPZ: Container, Frozen Donor Tissue Storage

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 6
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1986: 3
- 1987: 1
- 1994: 1
- 2002: 1

## Most-cited predicates
- K915471: Cryobag (1994), cited by 1

Source page: https://510kreport.com/product-code/LPZ
Data by year (CSV): https://510kreport.com/product-code/LPZ.csv