# K993122: MSP M/K Blade

- Pathway: 510(k) (Traditional)
- Applicant: Medical Sterile Products, Inc.
- Decided: Mar 16, 2000 after 178 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: 2 generations back to K962661 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980510: Keratome Blade (135 Micron, Model 300135), (160 Micron, Model 300160), (200 Micron, Model 30020), Micro Specialties, Inc. (1998) Summary page 2.
- K980508: Keratome Blade, Chirom Model Alk 500500; Keratome Blade, S.C.M.D. Model Turokeratome 400400, Micro Specialties, Inc. (1998) Summary page 2.
- K972727: Cbalk-1000 Blade, Howard Instruments, Inc. (1997) Summary page 2.
- K962661: ML Microkeratome Blade, Med-Logics, Inc. (1996) Summary page 2.
- (no number) Universal Refractive Instruments, B. Graczyk, Inc.: named in the summary without a submission number

## Indications for use
The MSP/MK Blade (#507-0028) is designed as a replacement blade for the Chiron Hansatome #507-0036-01 microkeratome for lamellar resection of the cornea.

Source page: https://510kreport.com/device/K993122
Methodology: https://510kreport.com/methodology