Inquis Medical: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Inquis Medical” (first 2023, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 56 days. Since 2017 the median was 56 days, against 70 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 |
|---|---|---|
| 2023 | 1 | 55 |
| 2024 | 2 | 75 |
| 2025 | 3 | 33 |
| 2026 | 4 | 64 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Inquis Medical took a median 56 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 70 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | 5 | 5 |
| QEZ | Aspiration Thrombectomy Catheter | 3 | 3 |
| CAC | Apparatus, Autotransfusion | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
Review panels
- Cardiovascular (10)
Most recent Inquis Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261105 | Powered Aventus Thrombectomy System | QEZ | 2026-07-27 | 115 |
| K262030 | Aventus Thrombectomy System | QEZ | 2026-07-15 | 28 |
| K260091 | Aventus Introducer Sheath | DYB | 2026-04-13 | 91 |
| K253925 | Aventus Thrombectomy System | QEZ | 2026-01-15 | 38 |
| K251189 | Aventus Thrombectomy System | QEW | 2025-06-13 | 57 |
| K250668 | Aventus Thrombectomy System (IM-2100) | QEW | 2025-03-25 | 20 |
| K250202 | Aventus Thrombectomy System | QEW | 2025-02-26 | 33 |
| K240426 | Aventus Clot Management System | CAC | 2024-05-14 | 91 |
| K240117 | Aventus Thrombectomy System (IM-2001/IM-0002) | QEW | 2024-03-15 | 59 |
| K232730 | Aventus Thrombectomy System | QEW | 2023-11-01 | 55 |
Recalls
openFDA lists no recalls under a recalling firm named Inquis Medical.
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.
Device clinical trials
An industry sponsor named Inquis Medical is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05907564: Aventus Thrombectomy System Pulmonary Embolism Clinical Study (Active not recruiting, started 2023-09-20)
Frequently asked questions
How many FDA 510(k) clearances are listed under Inquis Medical?
FDA lists 10 510(k) clearances under the applicant name “Inquis Medical” (first 2023, latest 2026), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Inquis Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Inquis Medical is 56 days. Since 2017: 56 days, versus 70 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Inquis Medical?
The most frequent FDA product codes under this applicant name are QEW (Peripheral Mechanical Thrombectomy With Aspiration, 5); QEZ (Aspiration Thrombectomy Catheter, 3); CAC (Apparatus, Autotransfusion, 1).
Next steps
- See all 10 Inquis Medical clearances with predicates and recalls
- Run predicate analysis for product code QEW, Inquis Medical'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.