Acutus Medical, Inc.: FDA clearances and approvals
Acutus Medical, Inc. has 24 FDA 510(k) clearances (first 2017, latest 2023), across 4 product codes in 1 review panel. Median 510(k) review time: 94 days. Since 2017 its median was 94 days, against 91 days for all cleared 510(k)s in the same product codes. openFDA lists 4 product recalls by a recalling firm named Acutus Medical, Inc. It is the industry lead sponsor of 8 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 3 | 200 |
| 2018 | 1 | 252 |
| 2019 | 4 | 84 |
| 2020 | 4 | 112 |
| 2021 | 4 | 30 |
| 2022 | 5 | 84 |
| 2023 | 3 | 60 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Acutus Medical, Inc.'s cleared 510(k)s took a median 94 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | 12 | 12 |
| DYB | Introducer, Catheter | 6 | 6 |
| DRA | Catheter, Steerable | 3 | 3 |
| MTD | Catheter, Intracardiac Mapping, High-Density Array | 3 | 3 |
Review panels
- Cardiovascular (24)
Most recent Acutus Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233691 | FlexCath Cross Transseptal Solution | DYB | 2023-12-17 | 31 |
| K231091 | AcQMap High Resolution Imaging and Mapping System | DQK | 2023-07-10 | 84 |
| K230606 | AcQMap® High Resolution Imaging and Mapping System | DQK | 2023-05-02 | 60 |
| K222209 | AcQMap High Resolution Imaging and Mapping System | DQK | 2022-10-17 | 84 |
| K220784 | AcQMap High Resolution Imaging and Mapping System | DQK | 2022-07-01 | 106 |
| K210766 | AcQMap 3D Imaging and Mapping Catheter, Model 900009 | MTD | 2022-06-21 | 463 |
| K221044 | AcQGuide® VUE Steerable Sheath | DRA | 2022-05-05 | 27 |
| K220047 | AcQCross Qx Integrated Transseptal Dilator/Needle | DYB | 2022-02-08 | 34 |
| K212345 | AcQMap High Resolution Imaging and Mapping System | DQK | 2021-08-27 | 30 |
| K210680 | AcQMap High Resolution Imaging and Mapping System | DQK | 2021-08-05 | 150 |
14 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2020-02-25.
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
Acutus Medical, Inc. is the industry lead sponsor of 8 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05181878: AcQMap 2.1 With Electro-Magnetic Tracking System Feasibility Study (EMT Feasibility Study) (Completed, started 2021-12-29)
- NCT05113056: AcQForce Pulsed Field Ablation-CE (Completed, started 2021-11-11)
- NCT04658940: AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter) (Completed, started 2021-03-25)
- NCT03368781: AcQMap Objectively Visualize the Etiology of Recurrent AF Following a Failed AF Ablation (Completed, started 2018-04-12)
- NCT02825992: Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation (Completed, started 2016-10-17)
Frequently asked questions
How many FDA 510(k) clearances does Acutus Medical, Inc. have?
Acutus Medical, Inc. has 24 FDA 510(k) clearances (first 2017, latest 2023), across 4 product codes in 1 review panel.
How long does FDA take to clear Acutus Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Acutus Medical, Inc.'s cleared 510(k)s is 94 days. Since 2017: 94 days, versus 91 days for all cleared 510(k)s in the same product codes.
What devices does Acutus Medical, Inc. make?
Its most frequent FDA product codes are DQK (Computer, Diagnostic, Programmable, 12); DYB (Introducer, Catheter, 6); DRA (Catheter, Steerable, 3).
Has Acutus Medical, Inc. had device recalls?
openFDA lists 4 product recalls in 1 recall event by a recalling firm whose name matches Acutus Medical, Inc; the most recent began 2020-02-25. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 24 Acutus Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQK, Acutus Medical, Inc.'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.