510(k) Report

FDA applicant

Voluntis Sa.

Suresnes, FR6 decisions2016–20251 recall

FDA records 6 decisions for Voluntis Sa. (Suresnes, FR) from 2016 to 2025: 6 510(k) clearances. Most are in product codes NDC (Calculator, Drug Dose) and CAF (Nebulizer (Direct Patient Interface)). Since 2016 its 510(k)s took a median of 120 days from receipt to decision, against 189 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Voluntis”.

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

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

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

FDA decisions per year

1in 2025

2016: 12017: 22021: 12023: 12025: 1
2016high 2 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2016high 1 (2018) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Voluntis Sa. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Voluntis Sa.’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?

  • NDCCalculator, Drug Dose5decisions
  • CAFNebulizer (Direct Patient Interface)1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 120 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 189 days; 4 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 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.

  • K161433Insulia Diabetes Management CompanionVoluntis Sa. · 20162cite it
  • K172177Insulia Diabetes Management CompanionVoluntis Sa. · 20171cites it
  • K170669Insulia Diabetes Management CompanionVoluntis Sa. · 20171cites it

What has FDA decided for it lately?

  • K250022HeroTracker SenseVoluntis · 2025
  • K232451Insulia Bolus CompanionVoluntis Sa. · 2023
  • K202596Insulia Diabetes Management CompanionVoluntis Sa. · 2021
  • K172177Insulia Diabetes Management CompanionVoluntis Sa. · 20171 recall
  • K170669Insulia Diabetes Management CompanionVoluntis Sa. · 20171 recall
  • K161433Insulia Diabetes Management CompanionVoluntis Sa. · 2016

All 5 as Voluntis Sa. →The one decision as Voluntis →

What has been recalled?

1 recall linked to its devices; the latest:

  • K170669Insulia Diabetes Management CompanionOct 8, 2018Class II