Rapid-Medical , Ltd.: FDA clearances and approvals
Rapid-Medical , Ltd. has 3 FDA 510(k) clearances (first 2020, latest 2026), plus 1 De Novo decision, across 3 product codes in 2 review panels. Median 510(k) review time: 304 days. Since 2017 its median was 304 days, against 134 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 304 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 226 |
| 2025 | 0 | — |
| 2026 | 1 | 358 |
Review time against the same product codes
Since 2017, Rapid-Medical , Ltd.'s cleared 510(k)s took a median 304 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MOF | Guide, Wire, Catheter, Neurovasculature | 2 | 2 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| PUU | Temporary Coil Embolization Assist Device | 1 | 0 |
Review panels
- Neurology (3)
- Cardiovascular (1)
Most recent Rapid-Medical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253146 | Hyperdrive 35 Guidewire | DQX | 2026-09-18 | 358 |
| K233791 | Drivewire 24 Guidewire | MOF | 2024-07-11 | 226 |
| K200374 | Columbus Guidewire | MOF | 2020-12-14 | 304 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170064 | De Novo | Temporary Coil Embolization Assist Device | 2019-04-24 |
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.
Frequently asked questions
How many FDA 510(k) clearances does Rapid-Medical , Ltd. have?
Rapid-Medical , Ltd. has 3 FDA 510(k) clearances (first 2020, 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 304 days. Since 2017: 304 days, versus 134 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 MOF (Guide, Wire, Catheter, Neurovasculature, 2); DQX (Wire, Guide, Catheter, 1); PUU (Temporary Coil Embolization Assist Device, 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 3 Rapid-Medical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MOF, 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.