510(k) Report

FDA applicant

Electrochemical Drug Delivery, Inc.

San Diego, CA2 decisions1991–19920 recalls

FDA records 2 decisions for Electrochemical Drug Delivery, Inc. (San Diego, CA) from 1991 to 1992: 2 510(k) clearances. All are in product code FRN (Pump, Infusion). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Electrochemical Drug Delivery, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Electrochemical Drug Delivery, 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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Other applicant names beginning “Electrochemical”

FDA records each applicant name separately; these may or may not be the same firm.