Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Glaukos medical devices: approvals, recalls and adverse events

Stock: GKOS. Includes companies and brands it has bought. Official US government data, updated September 2026.

510(k) clearances

De Novo: 0

PMA approvals

43 supplements

Recalled products

- class I

Adverse event reports

1,539

- deaths reported

How many recalls does Glaukos have?

Glaukos has - recalled medical device products in - recall actions in the records, - of them class I (the most serious kind).

How many medical devices has Glaukos had cleared or approved?

2 510(k) clearances, 0 De Novo grants and 2 original PMA approvals for high-risk devices, plus 43 PMA supplements (changes to approved devices). The newest decision was on Apr 8, 2026.

How many adverse event reports name Glaukos devices?

1,539 reports in total: - deaths, 1,029 injuries and 509 malfunctions were reported. 133 reports were received in 2025. A report alone does not show that the device caused the problem.

Clearances and approvals by year

Last 15 years

Year	510(k) clearance	De Novo grant	PMA approval	PMA supplement
2026	0	0	0	1
2025	0	0	0	2
2024	0	0	0	1
2023

Newest clearances and approvals

iStent infinite Trabecular Micro-Bypass System, Model iS3
K220032 · 510(k) clearance · Aug 2, 2022
iPrime Viscodelivery System
K212797 · 510(k) clearance · Jan 6, 2022
iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)
P170043 · PMA approval · Jun 21, 2018
GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L
P080030 · PMA approval · Jun 25, 2012

Newest recalls

Devices with the most adverse event reports

By product code, all years

Intraocular Pressure Lowering Implant (OGO, class 3)1,343
Implant, Eye Valve (KYF, class 2)186
Pump, Infusion, Ophthalmic (MRH, class 2)6
Trephine, Manual, Ophthalmic (HRH, class 1)2
Ring, Ophthalmic (Flieringa) (HNH, class 1)1
Unit, Phacofragmentation (HQC, class 2)1

All device makers and procedures · GKOS stock page

Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to GKOS with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.

Year	Reports	Deaths
2026	80	-
2025	133	-
2024	148	-
2023	146	-
2022	138	-
2021	143	-
2020	120	-
2019	166	-
2018	149	-
2017	99	-
2016	85	-
2015	58	-
2014	50	-
2013	24	-