510(k) Report

FDA applicant

Pausch Medical GmbH

Erlangen, DE3 decisions2016–20231 recall

FDA records 3 decisions for Pausch Medical GmbH (Erlangen, DE) from 2016 to 2023: 3 510(k) clearances. Most are in product codes JAA (System, X-Ray, Fluoroscopic, Image-Intensified) and IZF (System, X-Ray, Tomographic). Its devices cite 4 predicates, 1 of them its own earlier devices. 1 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, radiology panel, where it files most

How often FDA has decided Pausch Medical GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2016: 12018: 12023: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2016high 1 (2017) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Pausch Medical GmbH by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JAASystem, X-Ray, Fluoroscopic, Image-Intensified2decisions
  • IZFSystem, X-Ray, Tomographic1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K161019Uroview FDPausch Medical GmbH · 20162cite it
  • K221949Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbH · 20231cites it

What has FDA decided for it lately?

  • K221949Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbH · 2023
  • K180651Uroview FD IIPausch Medical GmbH · 2018
  • K161019Uroview FDPausch Medical GmbH · 20161 recall

All 3 as Pausch Medical GmbH →

What has been recalled?

1 recall linked to its devices; the latest:

  • K161019Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for…Mar 14, 2017Class II

Other applicant names beginning “Pausch”

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

Pausch Corp. 9