Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Philosys, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151658 | Gmate Origin Blood Glucose Monitoring System | Philosys, Inc. | 2015-12-01 | 165 | 0 |
| K150299 | Gmate SMART Blood Glucose Monitoring System | Philosys, Inc. | 2015-11-19 | 286 | 0 |
| K141656 | GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD | Philosys, Inc. | 2015-10-02 | 469 | 0 |
| K131230 | GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APP | Philosys, Inc. | 2014-08-04 | 461 | 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