# K993225: Bladeworks Microkeratome Blade

- Pathway: 510(k) (Traditional)
- Applicant: Blade Works, Inc.
- Decided: Mar 20, 2000 after 175 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Bladeworks BW 9000 Microkeratome Blade, in conjunction with the Chiron ACS microkeratome, and the Bladeworks BW 1011 Microkeratome Blade, in conjunction with the Chiron Ilansatome microkeratome, is used to perform lamellar kcratoplasty procedures.

Source page: https://510kreport.com/device/K993225
Methodology: https://510kreport.com/methodology