510(k) Report

FDA applicant

Pixee Medical

Besançon, FR7 decisions2021–20260 recalls

FDA records 7 decisions for Pixee Medical (Besançon, FR) from 2021 to 2026: 7 510(k) clearances. Most are in product codes SBF (Orthopedic Augmented Reality) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 147 days from receipt to decision, against 123 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Pixee Medical S.A.S.”.

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

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

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

FDA decisions per year

1in 2025

2021: 12022: 22023: 12024: 12025: 12026 (partial year): 1
2021high 2 (2022) · low 1 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Pixee Medical by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pixee Medical’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?

  • SBFOrthopedic Augmented Reality6decisions
  • LLZSystem, Image Processing, Radiological1decision

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 147 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; 4 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 8 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.

  • K243975Knee+Pixee Medical · 20252cite it
  • K213922FX SPSPixee Medical · 20222cite it
  • K220104Knee+Pixee Medical · 20222cite it
  • K202750Knee+Pixee Medical · 20211cites it
  • K233899Knee+Pixee Medical · 20241cites it
  • K230789Knee+Pixee Medical · 20231cites it

What has FDA decided for it lately?

All 6 as Pixee Medical →The one decision as Pixee Medical S.A.S. →