FDA applicant

Kardium, Inc.

Burnaby, CA3 decisions2025–20250 recalls

FDA records 3 decisions for Kardium, Inc. (Burnaby, CA) in 2025: 2 510(k) clearances and 1 original PMA approval. Most are in product codes QZI (Percutaneous Cardiac Ablation Catheter For…) and DRA (Catheter, Steerable). 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, last Nov 3, 2026

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

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

FDA decisions per year

3in 2025

2025high 3 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Kardium, Inc. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Kardium, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?