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Hyperdrive 35 Guidewire (K253146): 510(k) cleared for Rapid-Medical , Ltd. vs Tempus ECG-MR (K254297): 510(k) cleared for Tempus AI, Inc.: FDAPulse comparison
Hyperdrive 35 Guidewire (K253146): 510(k) cleared for Rapid-Medical , Ltd.'s review days of 358 is 1.3x Tempus ECG-MR (K254297): 510(k) cleared for Tempus AI, Inc.'s 268 (98th percentile). Hyperdrive 35 Guidewire (K253146): 510(k) cleared for Rapid-Medical , Ltd. is dated 2026-09-18; Tempus ECG-MR (K254297): 510(k) cleared for Tempus AI, Inc. 2026-09-25.
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe
How does Hyperdrive 35 Guidewire (K253146): 510(k) cleared for Rapid-Medical , Ltd. compare to Tempus ECG-MR (K254297): 510(k) cleared for Tempus AI, Inc.?
| Field | Hyperdrive 35 Guidewire (K253146): 510(k) cleared for Rapid-Medical , Ltd. | Tempus ECG-MR (K254297): 510(k) cleared for Tempus AI, Inc. |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K253146 | K254297 |
| Device | Hyperdrive 35 Guidewire | Tempus ECG-MR |
| Applicant | Rapid-Medical , Ltd. | Tempus AI, Inc. |
| Specialty / panel | Cardiovascular | Cardiovascular |
| Product code | DQX | SBQ |
| Device class | 2 | 2 |
| Clearance type | Traditional | Traditional |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2025-09-25 | 2025-12-31 |
| Decision date | 2026-09-18 | 2026-09-25 |
| Review time (days) | 358 | 268 |
| Third-party review | Yes | No |
| Applicant location | Yokneam, IL | Chicago, IL, US |
| amount percentile | 98th | 90th |
| Predicate Speed & CAPA Advisory Opportunity Score | 60/100 | 61/100 |
| Peer rank and all 500 records (CSV) | 🔒 Click to unlock → | |
| Official source URLs for every peer record | 🔒 Click to unlock → | |
Official records: Hyperdrive 35 Guidewire (K253146): 510(k) cleared for Rapid-Medical , Ltd. · Tempus ECG-MR (K254297): 510(k) cleared for Tempus AI, Inc.
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