Atlas FDA

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

Biotope, Inc. — Predicate Candidate Screening

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

34 daysmedian FDA review time
103 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K905145ECLIPSE ICA CHOLESTEROLBiotope, Inc.1991-02-261030
K910302ECLIPSE ICA ANALYZERBiotope, Inc.1991-02-22290
K910256ECLIPSE ICA TSHBiotope, Inc.1991-02-22310
K905601ECLIPSE ICA TRIGLYCERIDESBiotope, Inc.1991-01-17350
K905719ECLIPSE ICA DIGOXINBiotope, Inc.1991-01-17270
K905602ECLIPSE ICA BUNBiotope, Inc.1991-01-16340
K905144ECLIPSE ICA GLUCOSEBiotope, Inc.1991-01-04500

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