Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rapid Medical Ltd. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
171 daysmedian FDA review time
573 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254006 | Drivewire 35 Guidewire | Rapid Medical Ltd. | 2026-07-17 | 214 | 0 |
| K253062 | Tigertriever 25 Revascularization Device | Rapid Medical Ltd. | 2026-03-12 | 171 | 0 |
| K251603 | Tigertriever 17 Ultra Revascularization Device | Rapid Medical Ltd. | 2025-10-06 | 132 | 0 |
| K233791 | Drivewire 24 Guidewire | Rapid-Medical , Ltd. | 2024-07-11 | 226 | 0 |
| DEN230064 | BraidE Embolization Assist Device | Rapid Medical Ltd. | 2024-02-21 | 155 | 0 |
| K230429 | Tigertriever 21 Revascularization Device, Tigertriever 17 Re | Rapid Medical Ltd. | 2023-04-17 | 59 | 0 |
| K220808 | Tigertriever 13 Revascularization Device | Rapid Medical Ltd. | 2022-07-25 | 129 | 0 |
| K203592 | Tigertriever and Tigertriever 17 Revascularization Devce | Rapid Medical Ltd. | 2021-03-23 | 105 | 0 |
| K200374 | Columbus Guidewire | Rapid-Medical , Ltd. | 2020-12-14 | 304 | 0 |
| DEN170064 | Comaneci, Comaneci Petit, Comaneci 17 | Rapid-Medical , Ltd. | 2019-04-24 | 573 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda