Cleared Traditional

TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 (K003036) - FDA 510(k) Clearance

Class I Ophthalmic device.

K003036 · Retinalabs.Com · Ophthalmic device
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Dec 2000
Decision
84d
Days
Class 1
Risk

K003036 is an FDA 510(k) clearance for the TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,10.... Classified as Device, Irrigation, Ocular Surgery (product code KYG), Class I - General Controls.

Submitted by Retinalabs.Com (Atlanta, US). The FDA issued a Cleared decision on December 22, 2000 after a review of 84 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.

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Submission Details

510(k) Number K003036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2000
Decision Date December 22, 2000
Days to Decision 84 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
26d faster than avg
Panel avg: 110d · This submission: 84d
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.