510(k) Report

FDA applicant

Ecential Robotics

Gieres, FR7 decisions2022–20261 recall

FDA records 7 decisions for Ecential Robotics (Gieres, FR) from 2022 to 2026: 7 510(k) clearances. Most are in product codes OLO (Orthopedic Stereotaxic Instrument) and OWB (Interventional Fluoroscopic X-Ray System). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 7 of them its own earlier devices. 1 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, neurology panel, where it files most

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

FDA decisions per year

1in 2025

2022: 32023: 12024: 12025: 12026 (partial year): 1
2022high 3 (2022) · low 1 (2023)2026

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1
2022high 1 (2026) · low 0 (2022)2026

Class I Class II/III not classified

FIG. 1 — Ecential Robotics by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ecential Robotics’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?

  • OLOOrthopedic Stereotaxic Instrument5decisions
  • OWBInterventional Fluoroscopic X-Ray System2decisions

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 90 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 3 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 13 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 7 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.

  • K220627SURGIVISIO DeviceEcential Robotics · 20222cite it
  • K231886SURGIVISIO DeviceEcential Robotics · 20232cite it
  • K242914Op.n (TM) NavigationEcential Robotics · 20251cites it
  • K220946SURGIVISIO DeviceEcential Robotics · 20221cites it
  • K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics · 20241cites it
  • K221028SURGIVISIO DeviceEcential Robotics · 20221cites it

What has FDA decided for it lately?

  • K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics · 2026
  • K242914Op.n (TM) NavigationEcential Robotics · 2025
  • K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics · 20241 recall
  • K231886SURGIVISIO DeviceEcential Robotics · 2023
  • K221028SURGIVISIO DeviceEcential Robotics · 2022
  • K220946SURGIVISIO DeviceEcential Robotics · 2022
  • K220627SURGIVISIO DeviceEcential Robotics · 2022

All 7 as Ecential Robotics →

What has been recalled?

1 recall linked to its devices; the latest:

  • K233228Velys Enabling Tech Robotic-Assist Station REF: 451611001Jul 23, 2026Class II