# Acutus Medical, Inc.

- Location (FDA's records): Carlsbad, CA
- FDA decisions: 24 (2017–2023): 24 510(k) clearances
- Product codes: DQK (12), DYB (6), MTD (3), DRA (3)
- 510(k) review time since 2016: median 84 days, against 132 for FDA's reviews in the same codes and years (14 of 19 faster)
- Predicates its devices cite: 27 (19 its own); citations of its devices by later devices: 19 (19 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- St Jude Medical: 2 (https://510kreport.com/company/st-jude-medical)
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Rhythm Xience, Inc. (Rxi): 2 (https://510kreport.com/company/rhythm-xience-rxi)
- Medtronic Cryocath, LP: 1 (https://510kreport.com/company/medtronic-cryocath)
- Galt Medical Corp.: 1 (https://510kreport.com/company/galt-medical)

## Its most-cited devices
- K210685: AcQCross Qx Integrated Transseptal Dilator/Needle (2021), cited by 2
- K193013: AcQMap High Resolution Imaging and Mapping System (2020), cited by 2
- K222209: AcQMap High Resolution Imaging and Mapping System (2022), cited by 2
- K170948: AcQMap High Resolution Imaging and Mapping System (2017), cited by 2
- K191392: AcQMap High Resolution Imaging and Mapping System (2019), cited by 1
- K162925: AcQGuide Steerable Sheath (2017), cited by 1

## Recent decisions
- K233691: FlexCath Cross Transseptal Solution (Dec 17, 2023)
- K231091: AcQMap High Resolution Imaging and Mapping System (Jul 10, 2023)
- K230606: AcQMap® High Resolution Imaging and Mapping System (May 2, 2023)
- K222209: AcQMap High Resolution Imaging and Mapping System (Oct 17, 2022)
- K220784: AcQMap High Resolution Imaging and Mapping System (Jul 1, 2022)
- K210766: AcQMap 3D Imaging and Mapping Catheter, Model 900009 (Jun 21, 2022)
- K221044: AcQGuide® VUE Steerable Sheath (May 5, 2022)
- K220047: AcQCross Qx Integrated Transseptal Dilator/Needle (Feb 8, 2022)

Source page: https://510kreport.com/company/acutus-medical