510(k) Report

FDA applicant

Elite Biomedical Solutions

Cincinnati, OH1 decision2022–20220 recalls

FDA records 1 decision for Elite Biomedical Solutions (Cincinnati, OH) in 2022: 1 510(k) clearance. All are in product code MRZ (Accessories, Pump, Infusion). 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, general hospital panel, where it files most

How often FDA has decided Elite Biomedical Solutions’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Elite Biomedical Solutions by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MRZAccessories, Pump, Infusion1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K220695Elite Biomedical Solutions Dose Request CordElite Biomedical Solutions · 2022

The one decision as Elite Biomedical Solutions →

Other applicant names beginning “Elite”

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

Elite Diagnostic, Ltd. 5Elite Technology, Inc. 5Elite Surgical Supplies (Pty), Ltd. 4Elite International, Inc. 4Elite Electromedical 1Elite Medical Supply of New York, LLC 1Elite Medical, Inc. 1