510(k) Report

FDA applicant

Barkey GmbH & Co. KG

Leopoldshoehe, DE2 decisions2007–20220 recalls

FDA records 2 decisions for Barkey GmbH & Co. KG (Leopoldshoehe, DE) from 2007 to 2022: 2 510(k) clearances. Most are in product codes KOC (Accessories, Blood Circuit, Hemodialysis) and LGZ (Warmer, Thermal, Infusion Fluid). Its devices cite 2 predicates, 0 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, gastroenterology and urology panel, where it files most

How often FDA has decided Barkey GmbH & Co. KG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2007: 12022: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Barkey 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?

  • KOCAccessories, Blood Circuit, Hemodialysis1decision
  • LGZWarmer, Thermal, Infusion Fluid1decision

Whose devices does it build on?

Its devices cite 2 predicates; 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.

  • K071909Prismacomfort, Model Autocontrol 3XPT with Autoline XPT 4RBarkey GmbH & Co. KG · 20072cite it

What has FDA decided for it lately?

  • K213191S-LineBarkey GmbH & Co. KG · 2022
  • K071909Prismacomfort, Model Autocontrol 3XPT with Autoline XPT 4RBarkey GmbH & Co. KG · 2007

All 2 as Barkey GmbH & Co. KG →