FDA applicant

Codonics, Inc.

Middleburg Heights, OH8 decisions1996–20250 recalls

FDA records 8 decisions for Codonics, Inc. (Middleburg Heights, OH) from 1996 to 2025: 8 510(k) clearances. Most are in product codes LMC (Camera, Multi Format, Radiological) and BSZ (Gas-Machine, Anesthesia). Its devices cite 14 predicates, 7 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Codonics.Incorporated”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

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

FDA decisions per year

1in 2025

2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Codonics, 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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Codonics, Inc.

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?