# K992978: Ricrokeratome Blade

- Pathway: 510(k) (Traditional)
- Applicant: Surgistar, Inc.
- Decided: Nov 16, 1999 after 74 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
Longest line of descent: 1 generation back to K941550 (1994). 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)
- K941550: Automatic Corneal Shaper Surgical Instrument, Chiron Vision Corp. (1994) Summary page 1.

## Indications for use
The Surgistar Microkeratome is indicated for use as a replacement blade in the Chiron Vision Automatic Corneal Shaper Surgical Instrument (ACS). The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.

Source page: https://510kreport.com/device/K992978
Methodology: https://510kreport.com/methodology