Philosys, Inc.
FDA Regulatory Profile
Philosys, Inc. has 0 FDA recalls, 2 inspections, 5 510(k) clearances and 1 compliance action on record.
- Latest inspection
- Mar 30, 2023 · OAI
- Latest 510(k)
- Dec 1, 2015
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 5 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 2 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3010172486 | Gunsan, Korea (The Republic Of) | 2 | Mar 30, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K151658 | Gmate Origin Blood Glucose Monitoring System | Dec 1, 2015 |
| K150299 | Gmate SMART Blood Glucose Monitoring System | Nov 19, 2015 |
| K141656 | GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEM | Oct 2, 2015 |
| K131230 | GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION | Aug 4, 2014 |
| K113636 | BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE) | Mar 8, 2013 |