# CVS Advanced PLUS Blood Glucose Monitoring System (K260689): 510(k) cleared for I-Sens, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 53/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260689 |
| Device | CVS Advanced PLUS Blood Glucose Monitoring System |
| Applicant | I-Sens, Inc. |
| Specialty / panel | Clinical Chemistry |
| Product code | NBW |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-03-03 |
| Decision date | 2026-10-02 |
| Review time (days) | 213 |
| Third-party review | No |
| Applicant location | Seoul, KR |

## Why this score
- 213-day review, longer than typical.
- Special 510(k): a modification of an existing device.
- Posted 34 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=K260689). 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.