Cleared Traditional

K990900 - MICROKERATOME, MODEL MK-2000

K990900 is an FDA 510(k) clearance for MICROKERATOME, manufactured by Nidek, Inc.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K990900 · Nidek, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K990900

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 110d · This submission: 190d
Pathway characteristics
Predicate-based equivalence.

HNO Device Classification - Class 1, General Controls

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.

Regulatory Peers - HNO Keratome, Ac-powered

All 59
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K990900.
ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS)
K993190 · Surgical Instrument Systems (Sis), Ltd. · Feb 2000
ULTRASHAPER KERATOME
K990227 · Lasersight Technologies, Inc. · Jan 2000
RICROKERATOME BLADE
K992978 · Surgistar, Inc. · Nov 1999
KERAVISION VACUUM RING SYSTEM
K984540 · Keravision, Inc. · Apr 1999
SUMMIT KRUMEICH-BARRAQUER MICROKERATOME
K980675 · Summit Technology, Inc. · Dec 1998
MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI)
K981554 · Micra Instruments , Ltd. · Dec 1998