# K020122: MB 102 Millennium Blades

- Pathway: 510(k) (Traditional)
- Applicant: Millennium Biomedical, Inc.
- Decided: Feb 15, 2002 after 32 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 K913697 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972808: Hansatome Microkeratome, Chiron Vision Corp. (1997) Summary page 2.

## Indications for use
The MB 102 Millennium blade is intended to be used as a replacement blade for the Chiron Hansatome™ Microkeratome.

Source page: https://510kreport.com/device/K020122
Methodology: https://510kreport.com/methodology