510(k) Report

FDA applicant

Trumpf Medical Systems, Inc.

Charleston, SC1 decision2001–20013 recalls

FDA records 1 decision for Trumpf Medical Systems, Inc. (Charleston, SC) in 2001: 1 510(k) clearance. All are in product code FSY (Light, Surgical, Ceiling Mounted). Its devices cite 1 predicate, 0 of them its own earlier devices. 3 recalls are 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 Trumpf Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Trumpf Medical Systems, Inc. since 2007.

Recalls per year

1in 2015

2012: 12013: 12015: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Trumpf Medical Systems, 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?

  • FSYLight, Surgical, Ceiling Mounted1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K011693Trumpf Surgical Lights, Models 301,501,701,1001Trumpf Medical Systems, Inc. · 20012cite it

What has FDA decided for it lately?

  • K011693Trumpf Surgical Lights, Models 301,501,701,1001Trumpf Medical Systems, Inc. · 20013 recalls

The one decision as Trumpf Medical Systems, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K011693Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual…Jul 27, 2015Class II
  • K011693Helion S Exam Light or H300 The device is intended to locally illuminate an examination…Feb 19, 2013Class II
  • K011693Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are…Sep 19, 2012Class II

Other applicant names beginning “Trumpf”

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

Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg 2Trumpf Medizin Systeme GmbH + Co. KG 1