510(k) Report

FDA applicant

Therenva Sas

Rennes, FR5 decisions2014–20220 recalls

FDA records 5 decisions for Therenva Sas (Rennes, FR) from 2014 to 2022: 5 510(k) clearances. Most are in product codes OWB (Interventional Fluoroscopic X-Ray System) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 78 days from receipt to decision, against 83 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 4 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, radiology panel, where it files most

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

FDA decisions per year

1in 2022

2014: 12016: 12017: 12021: 12022: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Therenva Sas by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OWBInterventional Fluoroscopic X-Ray System3decisions
  • LLZSystem, Image Processing, Radiological2decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 78 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 83 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 4 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.

  • K141475EndosizeTherenva Sas · 20142cite it
  • K160376EndoSizeTherenva Sas · 20162cite it
  • K212383EndoNautTherenva Sas · 20211cites it
  • K222070EndoNautTherenva Sas · 20221cites it
  • K171829EndoNautTherenva Sas · 20171cites it

What has FDA decided for it lately?

  • K222070EndoNautTherenva Sas · 2022
  • K212383EndoNautTherenva Sas · 2021
  • K171829EndoNautTherenva Sas · 2017
  • K160376EndoSizeTherenva Sas · 2016
  • K141475EndosizeTherenva Sas · 2014

All 5 as Therenva Sas →