# K980510: Keratome Blade (135 Micron, Model 300135), (160 Micron, Model 300160), (200 Micron, Model 30020)

- Pathway: 510(k) (Traditional)
- Applicant: Micro Specialties, Inc.
- Decided: May 1, 1998 after 80 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 K962661 (1996). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972727: Cbalk-1000 Blade, Howard Instruments, Inc. (1997) Summary page 2.
- K962661: ML Microkeratome Blade, Med-Logics, Inc. (1996) Summary page 2.

## Most influential descendants
- K993122: MSP M/K Blade (2000), 0 descendants of its own

## Indications for use
The Microspecialties, Inc., 300135, 300160 and 300200 keratome blades are designed for use with other manufacture’s keratome. These blades are for use in the Insight Technologies Instruments, Model K-SERIES Keratome.

Source page: https://510kreport.com/device/K980510
Methodology: https://510kreport.com/methodology