Cleared Traditional

MICROKERATOME OR THE MATE (K974598) - FDA 510(k) Clearance

Class I Ophthalmic device.

K974598 · Howard Instruments, Inc. · Ophthalmic device
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Apr 1998
Decision
134d
Days
Class 1
Risk

K974598 is an FDA 510(k) clearance for the MICROKERATOME OR THE MATE. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Howard Instruments, Inc. (Tuscaloosa, US). The FDA issued a Cleared decision on April 22, 1998 after a review of 134 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 Howard Instruments, Inc. devices

Submission Details

510(k) Number K974598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1997
Decision Date April 22, 1998
Days to Decision 134 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 110d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.