510(k) Report

FDA applicant

X6 Innovations

Paris, FR3 decisions2023–20240 recalls

FDA records 3 decisions for X6 Innovations (Paris, FR) from 2023 to 2024: 3 510(k) clearances. Most are in product codes HIR (Perineometer) and HGX (Pump, Breast, Powered). Since 2016 its 510(k)s took a median of 220 days from receipt to decision, against 187 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 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, obstetrics and gynecology panel, where it files most

How often FDA has decided X6 Innovations’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2023: 22024: 1
2023high 2 (2023) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — X6 Innovations by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like X6 Innovations’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • HIRPerineometer2decisions
  • HGXPump, Breast, Powered1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 220 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 187 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 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.

  • K231785Perifit PumpX6 Innovations · 20242cite it
  • K221476PerifitX6 Innovations · 20231cites it
  • K231780Perifit Care+X6 Innovations · 20231cites it

What has FDA decided for it lately?

  • K231785Perifit PumpX6 Innovations · 2024
  • K231780Perifit Care+X6 Innovations · 2023
  • K221476PerifitX6 Innovations · 2023

All 3 as X6 Innovations →