510(k) Report

FDA applicant

K2 Medical GmbH & Co. KG

Tuttlingen, DE2 decisions2012–20160 recalls

FDA records 2 decisions for K2 Medical GmbH & Co. KG (Tuttlingen, DE) from 2012 to 2016: 2 510(k) clearances. Most are in product codes HAE (Rongeur, Manual) and DXC (Clamp, Vascular). Its devices cite 3 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, neurology panel, where it files most

How often FDA has decided K2 Medical GmbH & Co. KG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2012: 12016: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — K2 Medical GmbH & Co. KG by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HAERongeur, Manual1decision
  • DXCClamp, Vascular1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K150468Laminectomy Rongeurs, Kerrison Rongeurs, IVD RongeursK2 Medical GmbH & Co. KG · 20161cites it

What has FDA decided for it lately?

  • K150468Laminectomy Rongeurs, Kerrison Rongeurs, IVD RongeursK2 Medical GmbH & Co. KG · 2016
  • K120492K2 Medical Vascular ClampsK2 Medical GmbH & Co. KG · 2012

All 2 as K2 Medical GmbH & Co. KG →