FDA applicant
Catheter Research, Inc.
FDA records 8 decisions for Catheter Research, Inc. (Indianapolis, IN) from 1994 to 2013: 8 510(k) clearances. Most are in product codes LKF (Cannula, Manipulator/Injector, Uterine) and BZT (Stethoscope, Esophageal, With Electrical…). Its devices cite 6 predicates, 2 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Catheter Research, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2013
2026 so far, outlined.
Recalls per year
1in 2015
Class I Class II/III not classified
Planning a device like Catheter Research, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Catheter”
FDA records each applicant name separately; these may or may not be the same firm.