Cleared Traditional

K020079 - BLADEWORKS MICROKERATOME BLADE, MODEL 7061

K020079 is an FDA 510(k) clearance for BLADEWORKS MICROKERATOME BLADE, manufactured by Blade Works, Inc.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K020079 · Blade Works, Inc. · Ophthalmic device
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Apr 2002
Decision
99d
Days
Class 1
Risk

K020079 is an FDA 510(k) clearance for the BLADEWORKS MICROKERATOME BLADE, MODEL 7061. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Blade Works, Inc. (San Marcos, US). The FDA issued a Cleared decision on April 19, 2002 after a review of 99 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K020079

510(k) Number K020079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2002
Decision Date April 19, 2002
Days to Decision 99 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 110d · This submission: 99d
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 82
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K020079.
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K014000 · Biovision AG · Mar 2002
MB 103 MILLENNIUM BLADES
K011833 · Millennium Biomedical, Inc. · Feb 2002
MB 102 MILLENNIUM BLADES
K020122 · Millennium Biomedical, Inc. · Feb 2002
K020079 · BLADEWORKS MICROKERATOME BLADE, MODEL 7061
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