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

Integra Neurocare, LLC — Predicate Candidate Screening

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

90 daysmedian FDA review time
216 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K002392VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING Integra Neurocare, LLC2000-11-02870
K992006NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33Integra Neurocare, LLC1999-08-17630
K981246BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONIntegra Neurocare, LLC1999-05-264150
K973525MAURICE WORLDWIDE SHUNT SYSTEMIntegra Neurocare, LLC1997-12-16900
K972994EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMSIntegra Neurocare, LLC1997-11-03830
K972261RIVETTI-LEVINSON INSTRALUMINAL SHUNTIntegra Neurocare, LLC1997-09-15900
K971617ENDOSCOPIC VENTRICULAR CATHETERIntegra Neurocare, LLC1997-07-31900
K970983PERITONEAL/CARDIAC CATHETERIntegra Neurocare, LLC1997-06-13870
K970658LUMBAR DRAINAGE ACCESSORY KITIntegra Neurocare, LLC1997-05-19870
K964371SHUNT TAP WITH ICP MONITORING ACCESS PORTIntegra Neurocare, LLC1997-01-31910
K961859NOVUS STANDARD AND PEDIATRIC VALVESIntegra Neurocare, LLC1996-12-162160
K963802SHUNT TAPIntegra Neurocare, LLC1996-12-12800

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