Cleared Traditional

KERATOME BLADE 200200 & 600600 (K020482) - FDA 510(k) Clearance

Class I Ophthalmic device.

K020482 · Micro Specialties, Inc. · Ophthalmic device
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Dec 2002
Decision
306d
Days
Class 1
Risk

K020482 is an FDA 510(k) clearance for the KERATOME BLADE 200200 & 600600. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Micro Specialties, Inc. (Milford, US). The FDA issued a Cleared decision on December 16, 2002 after a review of 306 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Micro Specialties, Inc. devices

Submission Details

510(k) Number K020482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2002
Decision Date December 16, 2002
Days to Decision 306 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
196d slower than avg
Panel avg: 110d · This submission: 306d
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.