Cleared Traditional

MED-LOGICS DISPOSABLE ALK TUBING (K010353) - FDA 510(k) Clearance

Class I Ophthalmic device.

K010353 · Med-Logics, Inc. · Ophthalmic device
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Apr 2001
Decision
80d
Days
Class 1
Risk

K010353 is an FDA 510(k) clearance for the MED-LOGICS DISPOSABLE ALK TUBING. Classified as Device, Irrigation, Ocular Surgery (product code KYG), Class I - General Controls.

Submitted by Med-Logics, Inc. (Laguna Niguel,, US). The FDA issued a Cleared decision on April 27, 2001 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4360 - 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 Med-Logics, Inc. devices

Submission Details

510(k) Number K010353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2001
Decision Date April 27, 2001
Days to Decision 80 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
30d faster than avg
Panel avg: 110d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYG Device, Irrigation, Ocular Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4360
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.