FDA applicant
Cardio Kinetics, Inc.
FDA records 5 decisions for Cardio Kinetics, Inc. (Mchenry, IL) from 1979 to 1982: 5 510(k) clearances. Most are in product codes DSB (Plethysmograph, Impedance) and DSF (Recorder, Paper Chart). 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 Cardio Kinetics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Cardio Kinetics, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Cardio Kinetics, 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