Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Glooko, Inc. with 5 510(k) clearances. The most recent is a 510(k) clearance dated May 1, 2026: EndoTool IV Cloud 1.0.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| May 1, 2026 | EndoTool IV Cloud 1.0K260910 · NDC | 510(k) clearances |
| Feb 2, 2018 | Glooko Mobile Insulin Dosing SystemK171450 · NDC | 510(k) clearances |
| Oct 17, 2013 | GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATIONK132272 · NBW | 510(k) clearances |
| Apr 25, 2013 | GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATIONK130886 · NBW | 510(k) clearances |
| Dec 21, 2012 | GLOOKO LOGBOOK CHARTSK122142 · NBW | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built