Atlas FDA

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

Ellipse A/S · Predicate Candidate Screening

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

144 daysmedian FDA review time
191 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S2020-03-261570
K180406Ellipse YdunEllipse A/S2018-03-15290
K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse SirEllipse A/S2016-09-161440
K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse InEllipse A/S2015-07-07950
K140670ELLIPSE I2PL+/ELLIPSE MULTIFLEX+Ellipse A/S2014-09-251910
K081408ELLIPSE MULTIFLEXEllipse A/S2008-10-171510
K072023ELLIPSE JUVIA, MODEL 9EJU7465Ellipse A/S2007-09-12510

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