Cleared Traditional

K030401 - DISPOSABLE M2-PE MICROKERATOME BLADES (FDA 510(k) Clearance)

Class I Ophthalmic device.

K030401 · Oasis Medical, Inc. · Ophthalmic device
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Jun 2003
Decision
133d
Days
Class 1
Risk

K030401 is an FDA 510(k) clearance for the DISPOSABLE M2-PE MICROKERATOME BLADES. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on June 19, 2003 after a review of 133 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.

View all Oasis Medical, Inc. devices

Submission Details

510(k) Number K030401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2003
Decision Date June 19, 2003
Days to Decision 133 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
23d slower than avg
Panel avg: 110d · This submission: 133d
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.