Cleared Traditional

K030401 - DISPOSABLE M2-PE MICROKERATOME BLADES

K030401 is an FDA 510(k) clearance for DISPOSABLE M2-PE MICROKERATOME BLADES, manufactured by Oasis Medical, Inc.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 133-day FDA review.

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

FDA 510(k) Submission Details - K030401

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.

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 19
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K030401.
PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD
K033182 · Surgin Surgical Instrumentation, Inc. · Jan 2004
MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME
K032978 · Ciba Vision Corporation · Oct 2003
CENTURION SES EPIKERATOME
K031735 · Ciba Vision Corporation · Aug 2003
HANSATOME EXCELLUS MICROKERATOME
K021640 · Bausch & Lomb, Inc. · Jun 2002
PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK
K011195 · Surgin Surgical Instrumentation, Inc. · Nov 2001
HANSATOME MICROKERATOME
K010260 · Bausch & Lomb, Inc. · Apr 2001