# SmartRead(TM) Medical Device Identifier (4100) (DEN260007): 510(k) cleared for BridgeSource Medical Corporation

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

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | DEN260007 |
| Device | SmartRead(TM) Medical Device Identifier (4100) |
| Applicant | BridgeSource Medical Corporation |
| Specialty / panel | Cardiovascular |
| Product code | SJJ |
| Device class | 2 |
| Clearance type | Direct |
| Decision | Unknown |
| Received | 2026-03-24 |
| Decision date | 2026-09-29 |
| Review time (days) | 189 |
| Third-party review | No |
| Applicant location | Austin, TX, US |

## Why this score
- 189-day review, longer than typical.
- Posted 37 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=DEN260007). 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.