Atlas FDA

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

Great Batch Medical — Predicate Candidate Screening

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

112 daysmedian FDA review time
391 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K181855RadialSeal Introducer KitGreat Batch Medical2018-07-26150
K130559MOBICATH BI-DIRECTIONAL GUIDING SHEATHGreat Batch Medical2013-05-24810
K122832MOBICATH TRANSSEPTAL NEEDLEGreat Batch Medical2012-12-19930
K112541Z FLEX-270TM STEERABLE SHEATHGreat Batch Medical2012-02-071591
K110051RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KITGreat Batch Medical2012-02-023911
K111644MOBICATH TRANSSEPTAL NEEDLEGreat Batch Medical2011-10-031120
K101784MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXXGreat Batch Medical2010-11-261542
K102540PTFE PORTABLE INTRODUCERGreat Batch Medical2010-11-16740
K093232OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCERGreat Batch Medical2010-03-151521
K093023PTFE PEELABLE INTRODUCERGreat Batch Medical2009-10-29300

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