FDA applicant
Echocath, Inc.
FDA records 6 decisions for Echocath, Inc. (Princeton, NJ) from 1993 to 2001: 6 510(k) clearances. Most are in product codes JOP (Transducer, Ultrasonic) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 2 predicates, 0 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
How often FDA has decided Echocath, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Echocath, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Echocath, 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