# K033236: Prizm Keratome Blade, Model MK8512M2

- Pathway: 510(k) (Traditional)
- Applicant: Surgin Surgical Instrumentation, Inc.
- Decided: Mar 26, 2004 after 172 days
- Product code: HNO (Keratome, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 886.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K041110: MB 105 Millennium Blades (2004), 0 descendants of its own

## Indications for use
The Prizm Keratome Blade VII is to be used as a replacement blade for the non-disposable Moria M2 keratome for lamellar resection of the cornea

Source page: https://510kreport.com/device/K033236
Methodology: https://510kreport.com/methodology