Atlas FDA

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

3M Espe AG — Predicate Candidate Screening

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

101 daysmedian FDA review time
120 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K140602FLASH PENTA MB QUICK, FLASH MB QUICK3M Espe AG2014-06-05870
K133400FLASH BITE3M Espe AG2014-03-061200
K120011HEISENBERG EFFECT SHADES3M Espe AG2012-01-13100
K110508SUGLUE-103M Espe AG2011-06-031010
K110302ADHESIVE EXL-7593M Espe AG2011-05-191060
K111257HEISENBERG DYEING LIQUIDS3M Espe AG2011-05-1390

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