Atlas FDA

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

Intratherapeutics, Inc. — Predicate Candidate Screening

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

76 daysmedian FDA review time
189 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K011184INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESISIntratherapeutics, Inc.2001-08-131170
K003997INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESISIntratherapeutics, Inc.2001-01-24290
K003040INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORIntratherapeutics, Inc.2000-12-28900
K003450INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESISIntratherapeutics, Inc.2000-12-07300
K001648INTRASTENT DOUBLESTRUT PARAMOUNTIntratherapeutics, Inc.2000-08-28900
K001257INTRACOIL STENTIntratherapeutics, Inc.2000-05-18290
K000864INTRASTENT DOUBLESTRUT XS STENTIntratherapeutics, Inc.2000-04-14280
K993904INTRASTENT DOUBLESTRUT LDIntratherapeutics, Inc.2000-02-01761
K992816MODIFICATION TO INTRASTENTIntratherapeutics, Inc.1999-10-15560
K992622INTRAMAX ITI GUIDE CATHETERIntratherapeutics, Inc.1999-09-29550
K990592INTRASTENT IIIntratherapeutics, Inc.1999-09-011890
K991929INTRASTENTIntratherapeutics, Inc.1999-08-04570
K990221INTRACOIL PERIPHERAL STENTIntratherapeutics, Inc.1999-06-021310
K981191ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65Intratherapeutics, Inc.1999-04-073700
K980290ITI STENTIntratherapeutics, Inc.1998-07-2117612

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