510(k) Report

FDA applicant

Volta Medical

Marseille, FR5 decisions2020–20250 recalls

FDA records 5 decisions for Volta Medical (Marseille, FR) from 2020 to 2025: 5 510(k) clearances. All are in product code DQK (Computer, Diagnostic, Programmable). Since 2016 its 510(k)s took a median of 119 days from receipt to decision, against 123 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Volta Medical’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2020: 12023: 22025: 2
2020high 2 (2023) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Volta Medical by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Volta Medical’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DQKComputer, Diagnostic, Programmable5decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 119 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 123 days; 2 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K201298VX1Volta Medical · 20205cite it
  • K223516VX1+Volta Medical · 20232cite it
  • K232616Volta AF-XplorerVolta Medical · 20231cites it
  • K243812Volta AF-XplorerVolta Medical · 20251cites it

What has FDA decided for it lately?

  • K251518Volta AF-Xplorer IIVolta Medical · 2025
  • K243812Volta AF-XplorerVolta Medical · 2025
  • K232616Volta AF-XplorerVolta Medical · 2023
  • K223516VX1+Volta Medical · 2023
  • K201298VX1Volta Medical · 2020

All 5 as Volta Medical →