510(k) Report

FDA applicant

Neal Dunning Assoc., Inc.

Bethesda, MD1 decision1995–19950 recalls

FDA records 1 decision for Neal Dunning Assoc., Inc. (Bethesda, MD) in 1995: 1 510(k) clearance. All are in product code IMD (Pack, Hot Or Cold, Disposable). 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 Neal Dunning Assoc., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Neal Dunning Assoc., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • IMDPack, Hot Or Cold, Disposable1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K953442Restore, Thermacells (Hot Pack I)Neal Dunning Assoc., Inc. · 19951cites it

What has FDA decided for it lately?

  • K953442Restore, Thermacells (Hot Pack I)Neal Dunning Assoc., Inc. · 1995

The one decision as Neal Dunning Assoc., Inc. →

Other applicant names beginning “Neal”

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

Neal & Assoc., Inc. 2