# VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System. (K260687): 510(k) cleared for Vivachek Biotech (Hangzhou) Co., Ltd.

**Predicate Speed & CAPA Advisory Opportunity Score:** 48/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260687 |
| Device | VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System. |
| Applicant | Vivachek Biotech (Hangzhou) Co., Ltd. |
| Specialty / panel | Clinical Chemistry |
| Product code | NBW |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-03-03 |
| Decision date | 2026-10-09 |
| Review time (days) | 220 |
| Third-party review | No |
| Applicant location | Hangzhou, CN |

## Why this score
- 220-day review, longer than typical.
- Posted 27 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=K260687). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.