Atlas FDA

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

Footprint Medical · Predicate Candidate Screening

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

151 daysmedian FDA review time
162 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K093026FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCERFootprint Medical2010-02-241480
K091214FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETERFootprint Medical2009-09-251510
K091213FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMENFootprint Medical2009-09-251510
K091488FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MOFootprint Medical2009-09-141180
K090576FOOTPRINT URINARY DRAINAGE CATHETERFootprint Medical2009-08-121620
K090559FOOTPRINT MEDICAL SILICONE FEEDING TUBEFootprint Medical2009-05-04630

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