# K011833: MB 103 Millennium Blades

- Pathway: 510(k) (Traditional)
- Applicant: Millennium Biomedical, Inc.
- Decided: Feb 15, 2002 after 248 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: 3 generations back to K935342 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980924: Plancon Microlamellar Keratome Evolution, Plancon Instruments (1998) Summary page 2.
- K002849: Precisionedge-Acc, Precisionedge-Acs, Precisionedge-LSK, and Precisionedge-CB Microkeatome Blades, Surgical Specialties Corp (2000) Summary page 2.

## Indications for use
The MB 103 Millennium blade is intended to be used as a replacement blade for the Moria CB Microkeratome.

Source page: https://510kreport.com/device/K011833
Methodology: https://510kreport.com/methodology