Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Glooko, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
261 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260910 | EndoTool IV Cloud 1.0 | Glooko, Inc. | 2026-05-01 | 43 | 0 |
| K171450 | Glooko Mobile Insulin Dosing System | Glooko, Inc. | 2018-02-02 | 261 | 0 |
| K132272 | GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION | Glooko, Inc. | 2013-10-17 | 87 | 0 |
| K130886 | GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION | Glooko, Inc. | 2013-04-25 | 27 | 0 |
| K122142 | GLOOKO LOGBOOK CHARTS | Glooko, Inc. | 2012-12-21 | 155 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda