FDA applicant
Cardionow, Inc.
FDA records 2 decisions for Cardionow, Inc. (Encinitas, CA) from 2000 to 2002: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 1 predicate, 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 Cardionow, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Cardionow, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Cardionow, 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