510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220032Substantially Equivalent

iStent infinite Trabecular Micro-Bypass System, Model iS3

Glaukos Corporation, San Clemente CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K220032 is the FDA 510(k) clearance record for iStent infinite Trabecular Micro-Bypass System, Model iS3, a class II device, cleared for Glaukos Corporation on under FDA product code KYF (Implant, Eye Valve). FDA records list 2 510(k) clearances for Glaukos Corporation, from to . As of , FDA records show no recalls naming K220032.

Clearance record

Decision date
Received
(209 days to decision)
Product code
KYF Implant, Eye Valve
Regulation
21 CFR 886.3920
Device class
Class II
Review panel
Ophthalmic
Applicant
Glaukos Corporation 229 Avenida Fabricante, San Clemente CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KYF

Trailing 12 months

FDA records hold no clearances under product code KYF in the trailing twelve months.

FDA records show no clearances under product code KYF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KYF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260