Cleared Traditional

K012698 - VANGUARD REPROCESSED PHACOEMULSIFICATION (FDA 510(k) Clearance)

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

K012698 · Vanguard Medical Concepts, Inc. · Ophthalmic device
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Nov 2001
Decision
87d
Days
Class 2
Risk

K012698 is an FDA 510(k) clearance for the VANGUARD REPROCESSED PHACOEMULSIFICATION. Classified as Needle, Phacoemulsification, Reprocessed (product code NKX), Class II - Special Controls.

Submitted by Vanguard Medical Concepts, Inc. (Lakeland, US). The FDA issued a Cleared decision on November 9, 2001 after a review of 87 days - a notably fast clearance 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: 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 Vanguard Medical Concepts, Inc. devices

Submission Details

510(k) Number K012698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2001
Decision Date November 09, 2001
Days to Decision 87 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
23d faster than avg
Panel avg: 110d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKX Needle, Phacoemulsification, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
Definition Needle For Phacoemulsification Device To Remove Cataractous Lens. Same As Needle For Main Phacoemulsification Device And Un-reprocessed Needle With Product Code Hqc, Except This Is A "reprocessed" Needle. The Phacoemulsification Device Is Not Reprocessed, Just The Needle. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).
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.