Glooko, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Glooko, Inc.” (first 2012, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 87 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 155 |
| 2013 | 2 | 57 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 261 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 43 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Glooko, Inc. took a median 152 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 202 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 3 | 3 |
| NDC | Calculator, Drug Dose | 2 | 2 |
Review panels
Most recent Glooko, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260910 | EndoTool IV Cloud 1.0 | NDC | 2026-05-01 | 43 |
| K171450 | Glooko Mobile Insulin Dosing System | NDC | 2018-02-02 | 261 |
| K132272 | GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION | NBW | 2013-10-17 | 87 |
| K130886 | GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION | NBW | 2013-04-25 | 27 |
| K122142 | GLOOKO LOGBOOK CHARTS | NBW | 2012-12-21 | 155 |
Recalls
openFDA lists no recalls under a recalling firm named Glooko, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Glooko, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02974816: Glooko mHealth Advantage Study (Completed, started 2017-05-15)
- NCT03091712: Insulin Degludec Titration Using Mobile Insulin Dosing System (Completed, started 2017-05-05)
Frequently asked questions
How many FDA 510(k) clearances are listed under Glooko, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Glooko, Inc.” (first 2012, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Glooko, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Glooko, Inc. is 87 days.
Which FDA product codes appear under Glooko, Inc.?
The most frequent FDA product codes under this applicant name are NBW (System, Test, Blood Glucose, Over The Counter, 3); NDC (Calculator, Drug Dose, 2).
Next steps
- See all 5 Glooko, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NBW, Glooko, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.