Cleared Traditional

K001464 - DISPOSABLE H-PE MICROKERATOME BLADES

K001464 is an FDA 510(k) clearance for DISPOSABLE H-PE MICROKERATOME BLADES, manufactured by Oasis. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K001464 · Oasis · Ophthalmic device
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Oct 2000
Decision
145d
Days
Class 1
Risk

K001464 is an FDA 510(k) clearance for the DISPOSABLE H-PE MICROKERATOME BLADES. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Oasis (Glendora, US). The FDA issued a Cleared decision on October 2, 2000 after a review of 145 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 devices

FDA 510(k) Submission Details - K001464

510(k) Number K001464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2000
Decision Date October 02, 2000
Days to Decision 145 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
35d slower than avg
Panel avg: 110d · This submission: 145d
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 15
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K001464.
CENTURION SES EPIKERATOME
K031735 · Ciba Vision Corporation · Aug 2003
HANSATOME EXCELLUS MICROKERATOME
K021640 · Bausch & Lomb, Inc. · Jun 2002
HANSATOME MICROKERATOME
K010260 · Bausch & Lomb, Inc. · Apr 2001
MICROKERATOME, MODEL MK-2000
K990900 · Nidek, Inc. · Sep 1999
HANSATOME MICROKERATOME
K972808 · Chiron Vision Corp. · Oct 1997
AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT
K941550 · Chiron Vision Corp. · Nov 1994