Cleared Traditional

K003820 - DISPOSABLE CB-PE MICROKERATOME BLADES

K003820 is an FDA 510(k) clearance for DISPOSABLE CB-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 87-day FDA review.

K003820 · Oasis Medical, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
87d
Days
Class 1
Risk

K003820 is an FDA 510(k) clearance for the DISPOSABLE CB-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 March 8, 2001 after a review of 87 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Oasis Medical, Inc. devices

FDA 510(k) Submission Details - K003820

510(k) Number K003820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2000
Decision Date March 08, 2001
Days to Decision 87 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 faster than avg
Panel avg: 110d · This submission: 87d
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 K003820.
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
ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508
K994015 · Surgin Surgical Instrumentation, Inc. · Mar 2000
MICROKERATOME, MODEL MK-2000
K990900 · Nidek, Inc. · Sep 1999
HANSATOME MICROKERATOME
K972808 · Chiron Vision Corp. · Oct 1997