Cleared Abbreviated

K221872 - ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K221872 · Nova Eye Inc. (Business Name Nova Eye Medical) · Ophthalmic device
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Mar 2023
Decision
275d
Days
Class 2
Risk

K221872 is an FDA 510(k) clearance for the ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System. Classified as Endoilluminator (product code MPA), Class II - Special Controls.

Submitted by Nova Eye Inc. (Business Name Nova Eye Medical) (Fremont, US). The FDA issued a Cleared decision on March 30, 2023 after a review of 275 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 876.1500 - the FDA ophthalmic device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Nova Eye Inc. (Business Name Nova Eye Medical) devices

Submission Details

510(k) Number K221872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2022
Decision Date March 30, 2023
Days to Decision 275 days
Submission Type Abbreviated
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
165d slower than avg
Panel avg: 110d · This submission: 275d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code MPA Endoilluminator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 Consultant

Eds Regulatory Consulting, Inc.
Evelyn De La Vega Stewart

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.