Cleared Traditional

K212797 - iPrime Viscodelivery System (FDA 510(k) Clearance)

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

K212797 · Glaukos · Ophthalmic device
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Jan 2022
Decision
126d
Days
Class 2
Risk

K212797 is an FDA 510(k) clearance for the iPrime Viscodelivery System. Classified as Pump, Infusion, Ophthalmic (product code MRH), Class II - Special Controls.

Submitted by Glaukos (San Clemente, US). The FDA issued a Cleared decision on January 6, 2022 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 880.5725 - 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 Glaukos devices

Submission Details

510(k) Number K212797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2021
Decision Date January 06, 2022
Days to Decision 126 days
Submission Type Traditional
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
16d slower than avg
Panel avg: 110d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MRH Pump, Infusion, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - MRH Pump, Infusion, Ophthalmic

All 18
Devices cleared under the same product code (MRH) and FDA review panel - the closest regulatory comparables to K212797.
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OMNI Surgical System
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