# K972727: Cbalk-1000 Blade

- Pathway: 510(k) (Traditional)
- Applicant: Howard Instruments, Inc.
- Decided: Oct 10, 1997 after 81 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.
3 later devices descend from it; 3 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K980508: Keratome Blade, Chirom Model Alk 500500; Keratome Blade, S.C.M.D. Model Turokeratome 400400 (1998), 1 descendant of its own
- K980510: Keratome Blade (135 Micron, Model 300135), (160 Micron, Model 300160), (200 Micron, Model 30020) (1998), 1 descendant of its own
- K993122: MSP M/K Blade (2000), 0 descendants of its own

## Indications for use
The CBALK-1000 blades are to be used with the Chiron Microkeratome.

Source page: https://510kreport.com/device/K972727
Methodology: https://510kreport.com/methodology