Rapid Medical Ltd.: FDA clearances and approvals
Rapid Medical Ltd. has 7 FDA 510(k) clearances (first 2021, latest 2026), plus 1 De Novo decision, across 3 product codes in 2 review panels. Median 510(k) review time: 132 days. Since 2017 its median was 132 days, against 129 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 4 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 105 |
| 2022 | 1 | 129 |
| 2023 | 1 | 59 |
| 2024 | 0 | — |
| 2025 | 1 | 132 |
| 2026 | 3 | 184 |
Review time against the same product codes
Since 2017, Rapid Medical Ltd.'s cleared 510(k)s took a median 132 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 129 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NRY | Catheter, Thrombus Retriever | 6 | 6 |
| MOF | Guide, Wire, Catheter, Neurovasculature | 1 | 1 |
| QZU | Temporary Embolization Assist Device, Peripheral | 1 | 0 |
Review panels
- Neurology (7)
- Cardiovascular (1)
Most recent Rapid Medical Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260617 | Tigertriever 13 Ultra Revascularization Device | NRY | 2026-08-28 | 184 |
| K254006 | Drivewire 35 Guidewire | MOF | 2026-07-17 | 214 |
| K253062 | Tigertriever 25 Revascularization Device | NRY | 2026-03-12 | 171 |
| K251603 | Tigertriever 17 Ultra Revascularization Device | NRY | 2025-10-06 | 132 |
| K230429 | Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device | NRY | 2023-04-17 | 59 |
| K220808 | Tigertriever 13 Revascularization Device | NRY | 2022-07-25 | 129 |
| K203592 | Tigertriever and Tigertriever 17 Revascularization Devce | NRY | 2021-03-23 | 105 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230064 | De Novo | Temporary Embolization Assist Device, Peripheral | 2024-02-21 |
Recalls
openFDA lists no recalls under a recalling firm named Rapid Medical Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Rapid Medical Ltd. is the industry lead sponsor of 4 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05152524: Distal Ischemic Stroke Treatment With Adjustable Low-profile Stentriever (Active not recruiting, started 2022-03-25)
- NCT04518670: Success in Comaneci-assist Coils Embolization Surveillance Study (SUCCESS) (Completed, started 2020-11-24)
- NCT03474549: Treatment With Intent to Generate Endovascular Reperfusion (Completed, started 2018-05-09)
- NCT01404403: Safety Study of the Rapid System for Acute Ischemic Stroke (Completed, started 2011-08)
Frequently asked questions
How many FDA 510(k) clearances does Rapid Medical Ltd. have?
Rapid Medical Ltd. has 7 FDA 510(k) clearances (first 2021, latest 2026), plus 1 De Novo decision, across 3 product codes in 2 review panels.
How long does FDA take to clear Rapid Medical Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Rapid Medical Ltd.'s cleared 510(k)s is 132 days. Since 2017: 132 days, versus 129 days for all cleared 510(k)s in the same product codes.
What devices does Rapid Medical Ltd. make?
Its most frequent FDA product codes are NRY (Catheter, Thrombus Retriever, 6); MOF (Guide, Wire, Catheter, Neurovasculature, 1); QZU (Temporary Embolization Assist Device, Peripheral, 1).
Has Rapid Medical Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Rapid Medical Ltd. Related entities may recall under other names.
Next steps
- See all 7 Rapid Medical Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NRY, Rapid Medical Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.