Q'Apel Medical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Q'Apel Medical, Inc.” (first 2019, latest 2024), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 103 days. Since 2017 the median was 103 days, against 119 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 2 | 59 |
| 2020 | 0 | — |
| 2021 | 1 | 45 |
| 2022 | 0 | — |
| 2023 | 2 | 240 |
| 2024 | 1 | 246 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Q'Apel Medical, Inc. took a median 103 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QJP | Catheter, Percutaneous, Neurovasculature | 3 | 3 |
| DQY | Catheter, Percutaneous | 2 | 2 |
| NRY | Catheter, Thrombus Retriever | 1 | 1 |
Review panels
- Neurology (4)
- Cardiovascular (2)
Most recent Q'Apel Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240746 | Neurovascular Access System Family | QJP | 2024-11-20 | 246 |
| K222786 | 072 Aspiration System | NRY | 2023-08-25 | 344 |
| K230322 | SelectFlex Neurovascular Access System Family | QJP | 2023-06-22 | 136 |
| K211893 | SelectFlex Neurovascular Access System Family | QJP | 2021-08-05 | 45 |
| K192525 | 087 Balloon Guide Catheter System | DQY | 2019-10-31 | 48 |
| K191664 | SelectFlex 072 Neurovascular Access System | DQY | 2019-08-30 | 70 |
Recalls
openFDA lists no recalls under a recalling firm named Q'Apel Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Q'Apel Medical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Q'Apel Medical, Inc.” (first 2019, latest 2024), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Q'Apel Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Q'Apel Medical, Inc. is 103 days. Since 2017: 103 days, versus 119 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Q'Apel Medical, Inc.?
The most frequent FDA product codes under this applicant name are QJP (Catheter, Percutaneous, Neurovasculature, 3); DQY (Catheter, Percutaneous, 2); NRY (Catheter, Thrombus Retriever, 1).
Next steps
- See all 6 Q'Apel Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QJP, Q'Apel Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.