# Volta Medical

- Location (FDA's records): Marseille, FR
- FDA decisions: 5 (2020–2025): 5 510(k) clearances
- Product codes: DQK (5)
- 510(k) review time since 2016: median 119 days, against 123 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 6 (5 its own); citations of its devices by later devices: 9 (5 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
- Biosense Webster, Inc.: 1 (https://510kreport.com/company/biosense-webster)

## Firms that cite its devices most
- Vektor Medical, Inc.: 2 (https://510kreport.com/company/vektor-medical)
- Rhythm Al, Ltd.: 1 (https://510kreport.com/company/rhythm-al)
- Physcade, Inc.: 1 (https://510kreport.com/company/physcade)

## Its most-cited devices
- K201298: VX1 (2020), cited by 5
- K223516: VX1+ (2023), cited by 2
- K232616: Volta AF-Xplorer (2023), cited by 1
- K243812: Volta AF-Xplorer (2025), cited by 1

## Recent decisions
- K251518: Volta AF-Xplorer II (Sep 12, 2025)
- K243812: Volta AF-Xplorer (May 9, 2025)
- K232616: Volta AF-Xplorer (Sep 27, 2023)
- K223516: VX1+ (Jan 21, 2023)
- K201298: VX1 (Sep 16, 2020)

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