Cleared Traditional

K001176 - DISPOSABLE MICROKERATOME BLADES-PE

K001176 is an FDA 510(k) clearance for DISPOSABLE MICROKERATOME BLADES-PE, 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 163-day FDA review.

K001176 · Oasis Medical, Inc. · Ophthalmic device
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Sep 2000
Decision
163d
Days
Class 1
Risk

K001176 is an FDA 510(k) clearance for the DISPOSABLE MICROKERATOME BLADES-PE. 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 September 21, 2000 after a review of 163 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 Oasis Medical, Inc. devices

FDA 510(k) Submission Details - K001176

510(k) Number K001176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2000
Decision Date September 21, 2000
Days to Decision 163 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 110d · This submission: 163d
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 73
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K001176.
MILLENNIUM BLADES, MODEL MB101
K003143 · Millennium Biomedical, Inc. · Dec 2000
PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES
K002849 · Surgical Specialties Corp · Oct 2000
DISPOSABLE H-PE MICROKERATOME BLADES
K001464 · Oasis · Oct 2000
REFRACTIVE SURGERY BLADES
K001806 · Millennium Biomedical, Inc. · Sep 2000
ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS
K001144 · Lasersight Technologies, Inc. · May 2000
BLADEWORKS MICROKERATOME BLADE
K993225 · Blade Works, Inc. · Mar 2000