510(k) Report

FDA applicant

Glaukos Corporation

San Clemente, CA4 decisions2012–20220 recalls

FDA records 4 decisions for Glaukos Corporation (San Clemente, CA) from 2012 to 2022: 2 510(k) clearances and 2 original PMA approvals. Most are in product codes OGO (Intraocular Pressure Lowering Implant) and KYF (Implant, Eye Valve). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Glaukos”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Glaukos Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2012: 12018: 12022: 2
2012high 2 (2022) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Glaukos Corporation by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OGOIntraocular Pressure Lowering Implant2decisions
  • KYFImplant, Eye Valve1decision
  • MRHPump, Infusion, Ophthalmic1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K220032iStent infinite Trabecular Micro-Bypass System, Model iS3Glaukos Corporation · 2022
  • K212797iPrime Viscodelivery SystemGlaukos · 2022
  • P170043iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)Glaukos Corporation · 2018
  • P080030Glaukos Istent Trabecular Bypass Stent Model GTS100R/LGlaukos Corporation · 2012

All 3 as Glaukos Corporation →The one decision as Glaukos →