Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

World of Medicine Lemke GmbH · Predicate Candidate Screening

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

85 daysmedian FDA review time
90 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K024251SIGHTFIXWorld of Medicine Lemke GmbH2003-03-18850
K023468ENDOSCOPIC LIGHT SOURCE XL180/L3World of Medicine Lemke GmbH2003-01-14900
K021717ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5World of Medicine Lemke GmbH2002-08-20890
K021456ER150/M2World of Medicine Lemke GmbH2002-08-01870
K020889ENDOSCOPIC LIGHT SOURCE XL202/L3World of Medicine Lemke GmbH2002-06-05780
K014158ENDOSCOPIC CAMERA TC804/C4World of Medicine Lemke GmbH2002-03-14851
K020336ENDOSCOPIC CAMERA MC404/C3World of Medicine Lemke GmbH2002-03-14410

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