Cleared Traditional

K984537 - KERATOME SYSTEM, MODEL K3000

K984537 is an FDA 510(k) clearance for KERATOME SYSTEM, manufactured by Insight Technologies Instruments, LLC. The device is a Class 1 Ophthalmic device with product code HMY cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K984537 · Insight Technologies Instruments, LLC · Ophthalmic device
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May 1999
Decision
144d
Days
Class 1
Risk

K984537 is an FDA 510(k) clearance for the KERATOME SYSTEM, MODEL K3000. 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 May 14, 1999 after a review of 144 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 Insight Technologies Instruments, LLC devices

FDA 510(k) Submission Details - K984537

510(k) Number K984537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1998
Decision Date May 14, 1999
Days to Decision 144 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
34d slower than avg
Panel avg: 110d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

HMY Device Classification - Class 1, General Controls

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.

Regulatory Peers - HMY Keratome, Battery-powered

Devices cleared under the same product code (HMY) and FDA review panel - the closest regulatory comparables to K984537.
BD K-4000 MICROKERATOME SYSTEM
K023092 · Becton, Dickinson & CO · Oct 2002
BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME
K022637 · Becton, Dickinson & CO · Oct 2002
CARRIAZO BARRAQUER MICROKERATOME
K981741 · Moria, Inc. · Jul 1998
KERATOME SYSTEM
K974243 · Insight Technologies Instruments, LLC · Jan 1998
VISI-DRAPE OPHTHALMIC DRAPES
K902857 · Visitec Co. · Jul 1990
OSCILLATING KNIFE AND ACCESSORIES
K781412 · Codman & Shurtleff, Inc. · Oct 1978