Cleared Traditional

K980510 - KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020)

K980510 is an FDA 510(k) clearance for KERATOME BLADE (135 MICRON, manufactured by Micro Specialties, Inc.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K980510 · Micro Specialties, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
80d
Days
Class 1
Risk

K980510 is an FDA 510(k) clearance for the KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 M.... Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Micro Specialties, Inc. (Milford, US). The FDA issued a Cleared decision on May 1, 1998 after a review of 80 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 Micro Specialties, Inc. devices

FDA 510(k) Submission Details - K980510

510(k) Number K980510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1998
Decision Date May 01, 1998
Days to Decision 80 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
30d faster than avg
Panel avg: 110d · This submission: 80d
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 41
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K980510.
FLAPMAKER DISPOSABLE MICROKERATOME
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K981071 · Med-Logics, Inc. · Jul 1998
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K980508 · Micro Specialties, Inc. · May 1998
SCMD-1000
K980985 · Howard Instruments, Inc. · May 1998
MICROKERATOME OR THE MATE
K974598 · Howard Instruments, Inc. · Apr 1998
PLANCON MICROLAMELLAR KERATOME EVOLUTION
K980924 · Plancon Instruments · Apr 1998