510(k) Report

FDA applicant

Newmark, Inc.

Washington, DC3 decisions2009–20160 recalls

FDA records 3 decisions for Newmark, Inc. (Washington, DC) from 2009 to 2016: 3 510(k) clearances. All are in product code NUH (Stimulator, Nerve, Transcutaneous…). Its devices cite 8 predicates, 3 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 Newmark, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2009: 12013: 12016: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Newmark, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Newmark, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • NUHStimulator, Nerve, Transcutaneous, Over-The-Counter3decisions

Whose devices does it build on?

Its devices cite 8 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 3 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.

  • K090042Painmaster MCT PatchNewmark, Inc. · 20094cite it
  • K130114Painmaster MCT PatchNewmark, Inc. · 20134cite it

What has FDA decided for it lately?

  • K151995Painmaster MCT PatchNewmark, Inc. · 2016
  • K130114Painmaster MCT PatchNewmark, Inc. · 2013
  • K090042Painmaster MCT PatchNewmark, Inc. · 2009

All 3 as Newmark, Inc. →