Volta Medical: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Volta Medical” (first 2020, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 119 days. Since 2017 the median was 119 days, against 122 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 |
|---|---|---|
| 2020 | 1 | 124 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 45 |
| 2024 | 0 | — |
| 2025 | 2 | 134 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Volta Medical took a median 119 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | 5 | 5 |
Review panels
- Cardiovascular (5)
Most recent Volta Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251518 | Volta AF-Xplorer II | DQK | 2025-09-12 | 119 |
| K243812 | Volta AF-Xplorer | DQK | 2025-05-09 | 149 |
| K232616 | Volta AF-Xplorer | DQK | 2023-09-27 | 30 |
| K223516 | VX1+ | DQK | 2023-01-21 | 60 |
| K201298 | VX1 | DQK | 2020-09-16 | 124 |
Recalls
openFDA lists no recalls under a recalling firm named Volta 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 Volta Medical is the lead sponsor of 6 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT06825104: Long-Term Evaluation of TAILORED Vs Anatomical Ablation Strategy for Persistent Atrial Fibrillation (Recruiting, started 2025-03-06)
- NCT06056271: Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation (Recruiting, started 2024-03-19)
- NCT06083012: Clinical and Healthcare Economic OutcoMes From ReAl-worlD Use in Europe of an AI Software During AF Ablation (Active not recruiting, started 2023-10-27)
- NCT05477147: Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion (Completed, started 2023-03-17)
- NCT05362656: AutoMatic disPERsion Tagging Function Preliminary Evaluation (Completed, started 2022-05-29)
Frequently asked questions
How many FDA 510(k) clearances are listed under Volta Medical?
FDA lists 5 510(k) clearances under the applicant name “Volta Medical” (first 2020, latest 2025), across 1 product code 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 Volta Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Volta Medical is 119 days. Since 2017: 119 days, versus 122 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Volta Medical?
The most frequent FDA product codes under this applicant name are DQK (Computer, Diagnostic, Programmable, 5).
Next steps
- See all 5 Volta Medical clearances with predicates and recalls
- Run predicate analysis for product code DQK, Volta 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.