# EASYMAX Voice Blood Glucose Monitoring System (K261293): 510(k) cleared for EPS Bio Technology Corp.

**Predicate Speed & CAPA Advisory Opportunity Score:** 59/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261293 |
| Device | EASYMAX Voice Blood Glucose Monitoring System |
| Applicant | EPS Bio Technology Corp. |
| Specialty / panel | Clinical Chemistry |
| Product code | NBW |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-04-20 |
| Decision date | 2026-10-23 |
| Review time (days) | 186 |
| Third-party review | No |
| Applicant location | Hsinchu, TW |

## Why this score
- 186-day review, longer than typical.
- Special 510(k): a modification of an existing device.
- Posted 12 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261293). Last refreshed: 2026-11-03T18:05:14.713Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.