# DEN200063: Kerasave

- Pathway: De Novo (Post-NSE)
- Applicant: Al.Chi.Mi.A. S.R.L
- Decided: May 2, 2022 after 578 days
- Product code: QCW (Corneal Storage Media With Preservatives Including Anti-Fungal)
- Device class: 2
- Regulation: 21 CFR 886.4320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
Kerasave is indicated for storage of human corneas at 2-8 C for up to 14 days. It is intended for prescription (Rx) use by physicians or highly skilled personnel, such as Eye Bank operators.

Source page: https://510kreport.com/device/DEN200063
Methodology: https://510kreport.com/methodology