# K030401: Disposable M2-PE Microkeratome Blades

- Pathway: 510(k) (Traditional)
- Applicant: Oasis Medical, Inc.
- Decided: Jun 19, 2003 after 133 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: 1 generation back to K002191 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 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)

## Most influential descendants
- K041110: MB 105 Millennium Blades (2004), 0 descendants of its own

## Indications for use
The OASIS Disposable M2-PE (Precision Edge) Microkeratome Blade (Catalog #0415) is designed as a replacement blade for the Moria M2 Microkeratome for lamellar resection of the cornea.

Source page: https://510kreport.com/device/K030401
Methodology: https://510kreport.com/methodology