FDA applicant
Ionetics, Inc.
FDA records 7 decisions for Ionetics, Inc. (Costa Mesa, CA) from 1981 to 1993: 7 510(k) clearances. Most are in product codes JFP (Electrode, Ion Specific, Calcium) and JGS (Electrode, Ion Specific, Sodium). 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 Ionetics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Ionetics, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Ionetics, Inc.’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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