Cleared Traditional

KERATOME SYSTEM (K974243) - FDA 510(k) Clearance

Class I Ophthalmic device.

K974243 · Insight Technologies Instruments, LLC · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
69d
Days
Class 1
Risk

K974243 is an FDA 510(k) clearance for the KERATOME SYSTEM. Classified as Keratome, Battery-powered (product code HMY), Class I - General Controls.

Submitted by Insight Technologies Instruments, LLC (Milford, US). The FDA issued a Cleared decision on January 20, 1998 after a review of 69 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 Insight Technologies Instruments, LLC devices

Submission Details

510(k) Number K974243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1997
Decision Date January 20, 1998
Days to Decision 69 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
41d faster than avg
Panel avg: 110d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HMY Keratome, Battery-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.