# K041110: MB 105 Millennium Blades

- Pathway: 510(k) (Traditional)
- Applicant: Millennium Biomedical, Inc.
- Decided: Oct 13, 2004 after 168 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 K002191 (2000). 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)
- K002191: Carriazo Barraquer II Microkeratome, Moria, Inc. (2000) Summary page 1.
- K022982: Med-Logics Microkeratome Blade, Model 7050CLB, Med-Logics, Inc. (2002) Summary page 1.
- K030401: Disposable M2-PE Microkeratome Blades, Oasis Medical, Inc. (2003) Summary page 1.
- K033236: Prizm Keratome Blade, Model MK8512M2, Surgin Surgical Instrumentation, Inc. (2004) Summary page 2.

## Indications for use
The MB 105 Millennium blade is intended to be used as a replacement blade for the Moria M2 Non-Disposable Microkeratome.

Source page: https://510kreport.com/device/K041110
Methodology: https://510kreport.com/methodology