Atlas FDA

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

Advanced Catheter Systems — Predicate Candidate Screening

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

24 daysmedian FDA review time
37 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K813577PRESSURE INDICATOR-REGULATORAdvanced Catheter Systems1982-01-29370
K813622INDEFLATORAdvanced Catheter Systems1982-01-22240
K813624ADVANCED CATHETER SYSTEMS CORONARY GUIDAdvanced Catheter Systems1982-01-22240
K813623SIMPSON-ROBERT CORONARY GUIDING CATHETAdvanced Catheter Systems1982-01-22240
K813578HEMOSTATIC SIDE-ARM ADAPTERAdvanced Catheter Systems1982-01-18260

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