Atlas FDA

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

Integra Neurosciences Implants S.A. — Predicate Candidate Screening

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

26 daysmedian FDA review time
136 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K081773OSV IIIntegra Neurosciences Implants S.A.2008-11-061360
K042558EQUI-FLOW VALVE AND SHUNT SYSTEMIntegra Neurosciences Implants S.A.2004-10-06150
K042192LOW FLOW OSV II HYDROCEPHALUS VALVEIntegra Neurosciences Implants S.A.2004-09-02210
K040201MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEMIntegra Neurosciences Implants S.A.2004-02-26280
K033698CONTOUR-FLEX VALVE AND SHUNT SYSTEMIntegra Neurosciences Implants S.A.2003-12-17220
K032817EXTERNAL DRAINAGE SETIntegra Neurosciences Implants S.A.2003-10-06260

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