Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Acutus Medical, Inc. · Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
105 daysmedian FDA review time
237 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233691 | FlexCath Cross Transseptal Solution | Acutus Medical, Inc. | 2023-12-17 | 31 | 0 |
| K231091 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2023-07-10 | 84 | 0 |
| K230606 | AcQMap® High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2023-05-02 | 60 | 0 |
| K222209 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2022-10-17 | 84 | 0 |
| K220784 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2022-07-01 | 106 | 0 |
| K210766 | AcQMap 3D Imaging and Mapping Catheter, Model 900009 | Acutus Medical, Inc. | 2022-06-21 | 463 | 0 |
| K221044 | AcQGuide® VUE Steerable Sheath | Acutus Medical, Inc. | 2022-05-05 | 27 | 0 |
| K220047 | AcQCross Qx Integrated Transseptal Dilator/Needle | Acutus Medical, Inc. | 2022-02-08 | 34 | 0 |
| K212345 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2021-08-27 | 30 | 0 |
| K210680 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2021-08-05 | 150 | 0 |
| K211100 | AcQGuide MAX Steerable Sheath | Acutus Medical, Inc. | 2021-05-14 | 31 | 0 |
| K210685 | AcQCross Qx Integrated Transseptal Dilator/Needle | Acutus Medical, Inc. | 2021-04-06 | 29 | 0 |
| K201015 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2020-12-01 | 228 | 0 |
| K201341 | AcQMap 3D Imaging and Mapping Catheter | Acutus Medical, Inc. | 2020-09-15 | 118 | 0 |
| K193013 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2020-02-11 | 105 | 0 |
| K193509 | AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross | Acutus Medical, Inc. | 2020-01-17 | 30 | 0 |
| K191392 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2019-09-06 | 105 | 0 |
| K192106 | AcQRef Introducer Sheath | Acutus Medical, Inc. | 2019-09-03 | 29 | 0 |
| K190131 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2019-04-02 | 64 | 0 |
| K181577 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2019-02-07 | 237 | 0 |
| K171557 | AcQRef Introducer Sheath | Acutus Medical, Inc. | 2018-02-06 | 252 | 0 |
| K170948 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2017-10-16 | 200 | 0 |
| K170819 | AcQMap 3D Imaging and Mapping Catheter | Acutus Medical, Inc. | 2017-10-16 | 210 | 0 |
| K162925 | AcQGuide Steerable Sheath | Acutus Medical, Inc. | 2017-04-06 | 169 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda