510(k) Report

FDA applicant

Berchtold GmbH & Co. KG

Charleston, SC3 decisions2002–20122 recalls

FDA records 3 decisions for Berchtold GmbH & Co. KG (Charleston, SC) from 2002 to 2012: 3 510(k) clearances. Most are in product codes FSY (Light, Surgical, Ceiling Mounted) and GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 2 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Berchtold Corp.”.

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 Berchtold GmbH & Co. KG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2009: 12012: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2024: 12026 (partial year): 1
2007high 1 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Berchtold GmbH & Co. KG 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 Mounted2decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K090378Chromophare E 668Berchtold GmbH & Co. KG · 20092cite it

What has FDA decided for it lately?

  • K120392Chromophare F 628 and F 528Berchtold GmbH & Co. KG · 20122 recalls
  • K090378Chromophare E 668Berchtold GmbH & Co. KG · 2009
  • K013668Berchtold Elektrotom 106 HittBerchtold Corp. · 2002

All 2 as Berchtold GmbH & Co. KG →The one decision as Berchtold Corp. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K120392Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001Feb 23, 2026Class II
  • K120392Chromophare Surgical Light System , REF CH00000001Feb 8, 2024Class II

Other applicant names beginning “Berchtold”

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

Berchtold Holding GmbH 16