Cleared Traditional

K990900 - MICROKERATOME, MODEL MK-2000 (FDA 510(k) Clearance)

Class I Ophthalmic device.

K990900 · Nidek, Inc. · Ophthalmic device
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Sep 1999
Decision
190d
Days
Class 1
Risk

K990900 is an FDA 510(k) clearance for the MICROKERATOME, MODEL MK-2000. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Nidek, Inc. (Fremont, US). The FDA issued a Cleared decision on September 24, 1999 after a review of 190 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4370 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Nidek, Inc. devices

Submission Details

510(k) Number K990900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1999
Decision Date September 24, 1999
Days to Decision 190 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 110d · This submission: 190d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HNO Keratome, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4370
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.