# Hyperdrive 35 Guidewire (K253146): 510(k) cleared for Rapid-Medical , Ltd.

**Predicate Speed & CAPA Advisory Opportunity Score:** 60/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K253146 |
| Device | Hyperdrive 35 Guidewire |
| Applicant | Rapid-Medical , Ltd. |
| Specialty / panel | Cardiovascular |
| Product code | DQX |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-09-25 |
| Decision date | 2026-09-18 |
| Review time (days) | 358 |
| Third-party review | Yes |
| Applicant location | Yokneam, IL |

## Why this score
- A long 358-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Reviewed through the third-party program.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253146). 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.