510(k) Report

FDA applicant

Echosens

Paris, FR11 decisions2013–20230 recalls

FDA records 11 decisions for Echosens (Paris, FR) from 2013 to 2023: 11 510(k) clearances. All are in product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). Since 2016 its 510(k)s took a median of 53 days from receipt to decision, against 64 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 12 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 Echosens’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2013: 12015: 22016: 12017: 22018: 12020: 12021: 22023: 1
2013high 2 (2015) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

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

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Which product codes does it file in?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic11decisions

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 53 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 64 days; 6 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 16 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 22 times; 12 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.

  • K160524FibroScan 530 CompactEchosens · 20166cite it
  • K123806FibroscanEchosens · 20133cite it
  • K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens · 20213cite it
  • K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens · 20183cite it
  • K212035FibroScan 230Echosens · 20212cite it
  • K150239FibroScanEchosens · 20152cite it

What has FDA decided for it lately?

  • K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens · 2023
  • K212035FibroScan 230Echosens · 2021
  • K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens · 2021
  • K200655FibroScan® 630Echosens · 2020
  • K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens · 2018
  • K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens · 2017
  • K172142FibroScan 430 Mini+Echosens · 2017
  • K160524FibroScan 530 CompactEchosens · 2016

All 11 as Echosens →