FDA applicant

Energy Concepts, Inc.

Carlsbad, CA1 decision1987–19870 recalls

FDA records 1 decision for Energy Concepts, Inc. (Carlsbad, CA) in 1987: 1 510(k) clearance. All are in product code MHX (Monitor, Physiological, Patient (With…). 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 Energy Concepts, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Energy Concepts, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Energy Concepts, 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

Other applicant names beginning “Energy”

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

Energy Life Systems Corp. 5 Energy Resources International Co., Ltd. Hsinchu Branch 1 Energy Resources International Co., Ltd. 1 Energy-Lab Technologies GmbH 1 Energy Delivery Solutions 1

Energy Concepts, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Energy”