510(k) Report

FDA applicant

Cardiocomm Solutions, Inc.

Victoria, B.C., CA9 decisions2002–20190 recalls

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, last Nov 3, 2026

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

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

FDA decisions per year

1in 2019

2011: 22012: 12014: 12019: 1
2007high 2 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cardiocomm Solutions, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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