Cleared Traditional

K993225 - BLADEWORKS MICROKERATOME BLADE

K993225 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 175-day FDA review.

K993225 · Blade Works, Inc. · Ophthalmic device
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Mar 2000
Decision
175d
Days
Class 1
Risk

K993225 is an FDA 510(k) clearance for the BLADEWORKS MICROKERATOME BLADE. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Blade Works, Inc. (Hillsboro, US). The FDA issued a Cleared decision on March 20, 2000 after a review of 175 days - an extended review 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: 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 Blade Works, Inc. devices

FDA 510(k) Submission Details - K993225

510(k) Number K993225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1999
Decision Date March 20, 2000
Days to Decision 175 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
65d slower than avg
Panel avg: 110d · This submission: 175d
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 49
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K993225.
DISPOSABLE CB-PE MICROKERATOME BLADES
K003820 · Oasis Medical, Inc. · Mar 2001
PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES
K002849 · Surgical Specialties Corp · Oct 2000
DISPOSABLE MICROKERATOME BLADES-PE
K001176 · Oasis Medical, Inc. · Sep 2000
MSP M/K BLADE
K993122 · Medical Sterile Products, Inc. · Mar 2000
ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508
K994015 · Surgin Surgical Instrumentation, Inc. · Mar 2000
ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS)
K993190 · Surgical Instrument Systems (Sis), Ltd. · Feb 2000