FDA applicant

Catheter Robotics, Inc.

Mount Olive, NJ3 decisions2012–20140 recalls

FDA records 3 decisions for Catheter Robotics, Inc. (Mount Olive, NJ) from 2012 to 2014: 2 510(k) clearances and 1 De Novo grant. Most are in product codes DXX (System, Catheter Control, Steerable) and PJB (Catheter Remote Control System). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Catheter Robotics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2012high 2 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Catheter Robotics, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Catheter Robotics, 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) Report

Other applicant names beginning “Catheter”

FDA records each applicant name separately; these may or may not be the same firm.

Catheter Technology Corp. 13 Catheter Innovations, Inc. 8 Catheter Research, Inc. 8 Catheter Research C/O Burditt, Bowles & Radzius 8 Catheter Connections, Inc. 7 Catheter Precision, Inc. 2 Catheter Sciences Co. 2 The Catheter Exchange, Inc. 1 Catheter, LLC 1 Catheter Corp. of America 1

Catheter Robotics, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Catheter”