FDA applicant
Axelgaard Mfg. Co., Ltd.
FDA records 11 decisions for Axelgaard Mfg. Co., Ltd. (Fallbrook, CA) from 1985 to 2014: 11 510(k) clearances. Most are in product codes GXY (Electrode, Cutaneous) and DRX (Electrode, Electrocardiograph). Its devices cite 7 predicates, 3 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 Axelgaard Mfg. Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2014
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Axelgaard Mfg. Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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