510(k) Report

FDA applicant

New Deantronics, Ltd.

Boulder, CO2 decisions1998–19981 recall

FDA records 2 decisions for New Deantronics, Ltd. (Boulder, CO) in 1998: 2 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). 1 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for New Deantronics, Ltd. since 2007.

Recalls per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — New Deantronics, Ltd. 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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions

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.

  • K982884Disposable Hand Switching Pencil, Rocker Switch Two Piece, SB 312RS, Two Disposable Hand Switching Pencil…New Deantronics, Ltd. · 19981cites it

What has FDA decided for it lately?

  • K982884Disposable Hand Switching Pencil, Rocker Switch Two Piece, SB 312RS, Two Disposable Hand Switching Pencil…New Deantronics, Ltd. · 1998
  • K982130Return Electrode Clamp Shell Cord Model RC 201New Deantronics, Ltd. · 19981 recall

All 2 as New Deantronics, Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K982130Neutralect Diathermy Cable, Unomedical Ltd., Ref code 3508M, and Ref Code 3405M.Jan 22, 2010