Atlas FDA

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

Esaote Europe B.V. · Predicate Candidate Screening

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

60 daysmedian FDA review time
129 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K161168MyLabSix Ultrasound SystemEsaote Europe B.V.2016-09-021290
K141486MYLABSIX ULTRASOUND SYSTEMEsaote Europe B.V.2014-07-11360
K101605MYLABONE ULTRASOUND SYSTEMEsaote Europe B.V.2010-08-31840
K083882MYLABFIVEEsaote Europe B.V.2009-01-30320
K070903MYLAB40Esaote Europe B.V.2007-07-02910
K062598IMT.LAB SOFTWAREEsaote Europe B.V.2006-10-31600
K061755MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEMEsaote Europe B.V.2006-08-07470

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