# K990900: Microkeratome, Model MK-2000

- Pathway: 510(k) (Traditional)
- Applicant: Nidek, Inc.
- Decided: Sep 24, 1999 after 190 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: 4 generations back to K935342 (1994). 14 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913697: Automatic Corneal Shaper, Hansa Research & Development, Inc. (1991). Our OCR of the scanned summary read K912697, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “AUTOMATED CORNEAL SHAPER”.
- K972808: Hansatome Microkeratome, Chiron Vision Corp. (1997) Summary page 1.
- K973294: Innovatome Microkeratome, Innovative Optics, Inc. (1997) Summary page 1.
- K981741: Carriazo Barraquer Microkeratome, Moria, Inc. (1998). Our OCR of the scanned summary read K981141, FDA’s number for Sargon Immediate Load Implant, Model D (Sargon Ent., Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CARRAZIO BARRAQUER”.
- K981155: Flapmaker Disposable Microkeratome, Hawken Industries (1998) Summary page 1.
- K974004: Automated Disposable Keratome (Adk), Lasersight Technologies, Inc. (1998) Summary page 1.

## Most influential descendants
- K032297: Disposable N-PE Mickrokeratome Blades (2003), 0 descendants of its own
- K022205: Disposable N-PE Microkeratome Blades (2002), 0 descendants of its own

## Indications for use
The Nidek MK-2000, Keratome is intended to make a flap by incising the cornea at a predetermined thickness and diameter using a high speed oscillation blade of stainless steel.

Source page: https://510kreport.com/device/K990900
Methodology: https://510kreport.com/methodology