Atlas FDA

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

Blockade Medical — Predicate Candidate Screening

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

64 daysmedian FDA review time
148 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K151760Barricade Embolization Coil SystemBlockade Medical2015-07-27280
K142513Barricade Embolization Coil SystemBlockade Medical2014-11-13660
K140104BARRICADE EMBOLIZATION COIL SYSTEMBlockade Medical2014-02-13290
K132482BARRICADE EMBOLIZATION COIL SYSTEMBlockade Medical2013-10-10630
K131475BARRICADE EMBOLIZATION COIL SYSTEMBlockade Medical2013-07-25640
K123338BARRICADE EMBOLIZATION COIL SYSTEMBlockade Medical2013-03-281480

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