# K032297: Disposable N-PE Mickrokeratome Blades

- Pathway: 510(k) (Special)
- Applicant: Oasis Medical, Inc.
- Decided: Aug 26, 2003 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: 5 generations back to K935342 (1994). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990900: Microkeratome, Model MK-2000, Nidek, Inc. (1999) Summary page 1.

## Indications for use
The OASIS Disposable N-PE Microkeratome Blade is designed as a replacement blade for the Nidek MK-2000 Microkeratome for lamellar resection of the cornea.

Source page: https://510kreport.com/device/K032297
Methodology: https://510kreport.com/methodology