510(k) Report

FDA applicant

Hemodia Sas

Labege, FR4 decisions2013–20230 recalls

FDA records 4 decisions for Hemodia Sas (Labege, FR) from 2013 to 2023: 4 510(k) clearances. All are in product code HRX (Arthroscope). Since 2016 its 510(k)s took a median of 251 days from receipt to decision, against 141 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 2 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, orthopedic panel, where it files most

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

FDA decisions per year

1in 2023

2013: 12020: 12021: 12023: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Hemodia Sas by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hemodia Sas’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?

  • HRXArthroscope4decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 251 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 141 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K192921Zeos Aqua Vision Pump and tubeHemodia Sas · 20201cites it
  • K203480DOUBLEFLO systemHemodia Sas · 20211cites it

What has FDA decided for it lately?

  • K221919DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing setsHemodia Sas · 2023
  • K203480DOUBLEFLO systemHemodia Sas · 2021
  • K192921Zeos Aqua Vision Pump and tubeHemodia Sas · 2020
  • K132883Hemodia Arthroscopy Pump Tube Sets (Hats)Hemodia Sas · 2013

All 4 as Hemodia Sas →