# K251320: XTRA4

- Pathway: 510(k) (Traditional)
- Applicant: Al.Chi.Mi.A. S.R.L
- Decided: Sep 11, 2025 after 135 days
- Product code: LYX (Media, Corneal 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 K924165 (1992). 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)
- K924165: Optisol-GS Corneal Storage Media, Chiron Intraoptics (1992) Summary page 5.

## Indications for use
XTRA4 is a corneal storage solution for storage of human cornea suitable for keratoplasty for up to 14 days under refrigeration (2-8°C).

Source page: https://510kreport.com/device/K251320
Methodology: https://510kreport.com/methodology