# K974243: Keratome System

- Pathway: 510(k) (Traditional)
- Applicant: Insight Technologies Instruments, LLC
- Decided: Jan 20, 1998 after 69 days
- Product code: HMY (Keratome, Battery-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: 2 generations back to K935342 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970377: Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories), Plancon Instruments (1997) Summary page 2.
- K935342: SCMD Keratome, S.C.M.D. Keratomes of Arizona (1994) Summary page 2.

## Indications for use
The Insight Technologies Instruments, Model K-1000 Keratome System is designed to produce a corneal flap.

Source page: https://510kreport.com/device/K974243
Methodology: https://510kreport.com/methodology