FDA applicant

Cadwell

Kennewick, WA2 decisions2013–20140 recalls

FDA records 2 decisions for Cadwell (Kennewick, WA) from 2013 to 2014: 2 510(k) clearances. Most are in product codes OMB (Automatic Event Detection Software For…) and PDQ (Neurosurgical Nerve Locator). 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, neurology panel, where it files most

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

FDA decisions per year

1in 2014

2013high 1 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Cadwell by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cadwell’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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Other applicant names beginning “Cadwell”

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

Cadwell Laboratories, Inc. 46 Cadwell Industries, Inc. 13 Cadwell Lab, Inc. 1

Cadwell

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 “Cadwell”