Cleared Traditional

K020482 - KERATOME BLADE 200200 & 600600

K020482 is an FDA 510(k) clearance for KERATOME BLADE 200200 & 600600, manufactured by Micro Specialties, Inc.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 306-day FDA review.

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

FDA 510(k) Submission Details - K020482

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.

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 43
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K020482.
DISPOSABLE N-PE MICKROKERATOME BLADES
K032297 · Oasis Medical, Inc. · Aug 2003
CENTURION SES EPIKERATOME
K031735 · Ciba Vision Corporation · Aug 2003
DISPOSABLE M2-PE MICROKERATOME BLADES
K030401 · Oasis Medical, Inc. · Jun 2003
DISPOSABLE N-PE MICROKERATOME BLADES
K022205 · Oasis Medical, Inc. · Oct 2002
HANSATOME EXCELLUS MICROKERATOME
K021640 · Bausch & Lomb, Inc. · Jun 2002
PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK
K011195 · Surgin Surgical Instrumentation, Inc. · Nov 2001