Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Ecential Robotics — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time
260 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics2026-07-221100
K242914Op.n(TM) NavigationEcential Robotics2025-03-071640
K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics2024-06-142600
K231886SURGIVISIO DeviceEcential Robotics2023-07-27300
K221028SURGIVISIO DeviceEcential Robotics2022-07-06900
K220946SURGIVISIO DeviceEcential Robotics2022-04-15140
K220627SURGIVISIO DeviceEcential Robotics2022-03-18140

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda