510(k) Report

FDA applicant

New Deantronics Taiwan, Ltd.

New Taipei City, TW19 decisions1998–20260 recalls

FDA records 19 decisions for New Deantronics Taiwan, Ltd. (New Taipei City, TW) from 1998 to 2026: 19 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 57 days from receipt to decision, against 99 for FDA’s reviews in the same codes and years. Its devices cite 14 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2025

2015: 12016: 12017: 12018: 12019: 42020: 32025: 12026 (partial year): 1
2007high 4 (2019) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like New Deantronics Taiwan, Ltd.’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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories19decisions

How long do its 510(k) reviews take?

Since 2016, its 12 510(k)s took a median of 57 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 99 days; 9 of its 12 were faster than that.

Whose devices does it build on?

Its devices cite 14 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 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.

  • K153265New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coatedNew Deantronics Taiwan, Ltd. · 20162cite it
  • K982742Disposable Hand Switching Pencil, Rocker Switch, One Piece and One Piece Holster Models SB 313 RS, SB 313 RSHNew Deantronics Taiwan, Ltd. · 19982cite it
  • K982748BI-Polar Cord Set 1.88 TR, BI-Polar Cord Set 1.83 TR, Model #'S SB223, SB 224New Deantronics Taiwan, Ltd. · 19981cites it
  • K982744Disposable Hand Switching Pencil, Push Button, 2 Piece with and Without Holster, Models SB 312PB, SB 312 PBHNew Deantronics Taiwan, Ltd. · 19981cites it
  • K982749Monopolar Foot Control Pencil, Model # SB 112-2New Deantronics Taiwan, Ltd. · 19981cites it

What has FDA decided for it lately?

  • K251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan, Ltd. · 2026
  • K251899E BlatorNew Deantronics Taiwan, Ltd. · 2025
  • K202962Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext.…New Deantronics Taiwan, Ltd. · 2020
  • K201221Electrosurgical GeneratorNew Deantronics Taiwan, Ltd. · 2020
  • K200455Trigger Switch and CordNew Deantronics Taiwan, Ltd. · 2020
  • K193004Monopolar CordNew Deantronics Taiwan, Ltd. · 2019
  • K191064Argon HandsetNew Deantronics Taiwan, Ltd. · 2019
  • K183126Electrosurgical accessoryNew Deantronics Taiwan, Ltd. · 2019

All 19 as New Deantronics Taiwan, Ltd. →