510(k) Report

FDA applicant

Ionetics, Inc.

Costa Mesa, CA7 decisions1981–19930 recalls

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, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

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.

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

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.

See the 510(k) Report