510(k) Report

FDA applicant

Dr. Mach GmbH & Co. KG

Ebersberg, DE4 decisions2010–20140 recalls

FDA records 4 decisions for Dr. Mach GmbH & Co. KG (Ebersberg, DE) from 2010 to 2014: 4 510(k) clearances. All are in product code FSY (Light, Surgical, Ceiling Mounted). Its devices cite 5 predicates, 2 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 Dr. Mach GmbH & Co. KG’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2010: 22014: 2
2010high 2 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Dr. Mach GmbH & Co. KG by year, 2010–2026Sources: 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 Mounted4decisions

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 2 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.

  • K093009Mach Led SCDr. Mach GmbH & Co. KG · 20103cite it
  • K093010Mach Led MCDr. Mach GmbH & Co. KG · 20102cite it

What has FDA decided for it lately?

  • K140460Mach Led 2SCDr. Mach GmbH & Co. KG · 2014
  • K140461Mach Led 2MCDr. Mach GmbH & Co. KG · 2014
  • K093009Mach Led SCDr. Mach GmbH & Co. KG · 2010
  • K093010Mach Led MCDr. Mach GmbH & Co. KG · 2010

All 4 as Dr. Mach GmbH & Co. KG →