Glaukos Corporation: FDA clearances and approvals
Glaukos Corporation has 2 FDA 510(k) clearances (first 2022, latest 2022), plus 2 PMA decisions, across 3 product codes in 1 review panel. Median 510(k) review time: 168 days. It is the industry lead sponsor of 35 device clinical trials on ClinicalTrials.gov. It files with the SEC as GLAUKOS Corp (GKOS).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 2 | 168 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Glaukos Corporation's cleared 510(k)s took a median 168 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 94 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OGO | Intraocular Pressure Lowering Implant | 2 | 0 |
| KYF | Implant, Eye Valve | 1 | 1 |
| MRH | Pump, Infusion, Ophthalmic | 1 | 1 |
Review panels
- Ophthalmic (4)
Most recent Glaukos Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220032 | iStent infinite Trabecular Micro-Bypass System, Model iS3 | KYF | 2022-08-02 | 209 |
| K212797 | iPrime Viscodelivery System | MRH | 2022-01-06 | 126 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P170043 | PMA | iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) | 2018-06-21 |
| P080030 | PMA | GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L | 2012-06-25 |
Recalls
openFDA lists no recalls under a recalling firm named Glaukos Corporation.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Glaukos Corporation is the industry lead sponsor of 35 device studies on ClinicalTrials.gov (4 active or recruiting). Most recent:
- NCT06066645: Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone (Recruiting, started 2023-09-14)
- NCT06057051: Glaukos® iStent Infinite Trabecular Micro-Bypass System in Subjects With Mild to Moderate Primary Open-angle Glaucoma (Recruiting, started 2023-09-01)
- NCT05127551: Clinical Study of Glaukos® Trabecular Micro-Bypass System Model iS3 Infinite Vs. Competitor (Active not recruiting, started 2021-11-27)
- NCT04624698: iStent Inject New Enrollment Post-Approval Study (Active not recruiting, started 2020-09-22)
- NCT03255785: Open-Angle Glaucoma Subjects With Cataract Treated With Cataract Surgery Plus One iStent and One iStent Supra (Completed, started 2018-05-01)
SEC filings
GLAUKOS Corp (GKOS): EDGAR filings, CIK 1192448. Matched by exact company name.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Glaukos Corporation's product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MRH)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MRH)
Frequently asked questions
How many FDA 510(k) clearances does Glaukos Corporation have?
Glaukos Corporation has 2 FDA 510(k) clearances (first 2022, latest 2022), plus 2 PMA decisions, across 3 product codes in 1 review panel.
How long does FDA take to clear Glaukos Corporation's 510(k)s?
The median time from FDA receipt to decision across Glaukos Corporation's cleared 510(k)s is 168 days.
What devices does Glaukos Corporation make?
Its most frequent FDA product codes are OGO (Intraocular Pressure Lowering Implant, 2); KYF (Implant, Eye Valve, 1); MRH (Pump, Infusion, Ophthalmic, 1).
Has Glaukos Corporation had device recalls?
openFDA lists no recalls under a recalling firm name matching Glaukos Corporation. Related entities may recall under other names.
Next steps
- See all 2 Glaukos Corporation clearances with predicates and recalls
- Run predicate analysis for product code OGO, Glaukos Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.