Atlas FDA

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

Catheter Technology Corp. — Predicate Candidate Screening

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

37 daysmedian FDA review time
182 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K880571CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEMCatheter Technology Corp.1988-03-04230
K871080PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERCatheter Technology Corp.1987-08-121471
K871998GROSHONG CV CATHETER REPAIR KITCatheter Technology Corp.1987-06-24291
K860256BRAWN AND GROSHONG CATHETERSCatheter Technology Corp.1986-03-28630
K842577CATH-TECH POLYURETHANE UMBILICAL VESSCatheter Technology Corp.1985-03-132530
K842147CATH-TECH CHOLANGIOGRAPHY CATHETERCatheter Technology Corp.1984-10-021250
K840339UMBILICAL VESSEL CATHETERCatheter Technology Corp.1984-07-251820
K831386GROSHONG CATHETER, LONG TERM TYPECatheter Technology Corp.1983-10-141690
K831361BETA-PREGCatheter Technology Corp.1983-06-02370
K831365TESTCORP ANACatheter Technology Corp.1983-06-02370
K831366TESTCORP PREGCatheter Technology Corp.1983-06-02370
K831362TESTCORP CRPCatheter Technology Corp.1983-05-27310
K831363TESTCORP ASOCatheter Technology Corp.1983-05-16200

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