510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990900Substantially Equivalent

Microkeratome, Model Mk-2000

Nidek, Inc., Fremont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990900 is the FDA 510(k) clearance record for MICROKERATOME, MODEL MK-2000, a class I device, cleared for Nidek, Inc. on under FDA product code HNO (Keratome, Ac-Powered). FDA records list 21 510(k) clearances for Nidek, Inc., from to . As of , FDA records show no recalls naming K990900.

Clearance record

Decision date
Received
(190 days to decision)
Product code
HNO Keratome, Ac-Powered
Regulation
21 CFR 886.4370
Device class
Class I
Review panel
Ophthalmic
Applicant
Nidek, Inc. 47651 Westinghouse Dr., Fremont CA
510(k) summary
Summary
Third party review
No

Clearances, product code HNO

Trailing 12 months

FDA records hold no clearances under product code HNO in the trailing twelve months.

FDA records show no clearances under product code HNO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HNO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260