FDA applicant

Ultimate Concepts, Inc.

Irvine, CA3 decisions1994–20050 recalls

FDA records 3 decisions for Ultimate Concepts, Inc. (Irvine, CA) from 1994 to 2005: 3 510(k) clearances. Most are in product codes KPL (Colonic Irrigation System) and HQY (Sunglasses (Non-Prescription Including…). Its devices cite 2 predicates, 1 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, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Ultimate Concepts, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Ultimate”

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

Ultimate Wireforms, Inc. 6 Ultimate Development Corp. 1

Ultimate Concepts, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Ultimate”