FDA applicant

Burke, Inc.

Kansas City, KS7 decisions1984–20060 recalls

FDA records 7 decisions for Burke, Inc. (Kansas City, KS) from 1984 to 2006: 7 510(k) clearances. Most are in product codes INI (Vehicle, Motorized 3-Wheeled) and ILO (Pack, Hot Or Cold, Water Circulating). 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, physical medicine panel, where it files most

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

FDA decisions per year

No FDA decision for Burke, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Burke, 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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Other applicant names beginning “Burke”

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

Burke Neutech, Inc. 7 Burke Mobility Products 4

Burke, 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 “Burke”