FDA applicant

Omega Point Systems, LLC

Cincinnati, OH1 decision2005–20050 recalls

FDA records 1 decision for Omega Point Systems, LLC (Cincinnati, OH) in 2005: 1 510(k) clearance. All are in product code DJZ (Devices, Breath Trapping, Alcohol). Its devices cite 1 predicate, 0 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, clinical toxicology panel, where it files most

How often FDA has decided Omega Point Systems, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Omega Point Systems, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Omega”

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

Omega Medical Electronics 21 Omega Medical Imaging, Inc. 15 Omega-Med Intl., Inc. 9 Omega Laboratories, Inc. 9 Omega Medical Diagnostics 5 Omega Silicone, Inc. 5 Omega Universal Technologies, Ltd. 3 Omega Surgical Instruments, Inc. 3 Omega Medical Corp. 2 Omega Mark-3 Pen Corp. 1 Omega Technologies, Inc. 1 Omega Critical Care Limited 1

Omega Point Systems, LLC

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Omega”