Cleared Traditional

K081877 - ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K081877 · Dutch Ophthalmic Research Center International BV · Ophthalmic device
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Jan 2009
Decision
187d
Days
Class 2
Risk

K081877 is an FDA 510(k) clearance for the ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Dutch Ophthalmic Research Center International BV (Zuidland, NL). The FDA issued a Cleared decision on January 5, 2009 after a review of 187 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - 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 Dutch Ophthalmic Research Center International BV devices

Submission Details

510(k) Number K081877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2008
Decision Date January 05, 2009
Days to Decision 187 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
77d slower than avg
Panel avg: 110d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HQC Unit, Phacofragmentation

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