Cleared Traditional

K220032 - iStent infinite Trabecular Micro-Bypass System, Model iS3 (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence.

K220032 · Glaukos Corporation · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
209d
Days
Class 2
Risk

K220032 is an FDA 510(k) clearance for the iStent infinite Trabecular Micro-Bypass System, Model iS3. Classified as Implant, Eye Valve (product code KYF), Class II - Special Controls.

Submitted by Glaukos Corporation (San Clemente, US). The FDA issued a Cleared decision on August 2, 2022 after a review of 209 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3920 - 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 Corporation devices

Submission Details

510(k) Number K220032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2022
Decision Date August 02, 2022
Days to Decision 209 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
99d slower than avg
Panel avg: 110d · This submission: 209d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYF Implant, Eye Valve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3920
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ophthalmic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03639870 Unknown Interventional Industry-sponsored

Investigation of the Glaukos® Trabecular Micro-Bypass System, Model iS3, in Subjects With Refractory Glaucoma

A Prospective, Multicenter Clinical Investigation of the Glaukos® Trabecular Micro-Bypass System, Model iS3, in Subjects With Refractory Glaucoma

65
Patients (est.)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Glaucoma
Study design Single group
Eligibility All sexes · 45 Years+
Principal investigator Kerry Stephens, O.D.
Sponsor Glaukos Corporation (industry)
Started 2018-07-10 → Primary completion 2021-09-01
Primary outcome
Primary effectiveness endpoint
View full study on ClinicalTrials.gov