FDA applicant
Cardiocomm Solutions, Inc.
FDA records 9 decisions for Cardiocomm Solutions, Inc. (Victoria, B.C., CA) from 2002 to 2019: 9 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and DSH (Recorder, Magnetic Tape, Medical). Its devices cite 16 predicates, 7 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 Cardiocomm Solutions, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Cardiocomm Solutions, 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