FDA applicant

Burke Neutech, Inc.

Largo, FL7 decisions1993–19960 recalls

FDA records 7 decisions for Burke Neutech, Inc. (Largo, FL) from 1993 to 1996: 7 510(k) clearances. Most are in product codes ILO (Pack, Hot Or Cold, Water Circulating) and JFA (Exerciser, Finger, Powered). 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 Neutech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Burke Neutech, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Burke Neutech, 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, Inc. 7 Burke Mobility Products 4

Burke Neutech, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Burke”