Cleared Traditional

K992687 - MILLENIUM MICROKERATOME, MODEL IMD-001

K992687 is an FDA 510(k) clearance for MILLENIUM MICROKERATOME, manufactured by Industrial & Medical Design, Inc.. The device is a Class 1 Ophthalmic device with product code HMY cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K992687 · Industrial & Medical Design, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
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Sep 1999
Decision
45d
Days
Class 1
Risk

K992687 is an FDA 510(k) clearance for the MILLENIUM MICROKERATOME, MODEL IMD-001. Classified as Keratome, Battery-powered (product code HMY), Class I - General Controls.

Submitted by Industrial & Medical Design, Inc. (Los Angeles, US). The FDA issued a Cleared decision on September 24, 1999 after a review of 45 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 Industrial & Medical Design, Inc. devices

FDA 510(k) Submission Details - K992687

510(k) Number K992687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1999
Decision Date September 24, 1999
Days to Decision 45 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
65d faster than avg
Panel avg: 110d · This submission: 45d
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

All 7
Devices cleared under the same product code (HMY) and FDA review panel - the closest regulatory comparables to K992687.
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
KERATOME SYSTEM, MODEL K3000
K984537 · Insight Technologies Instruments, LLC · May 1999
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