510(k) Report

FDA applicant

Raumedic AG

Helmbrechts, DE6 decisions2011–20250 recalls

FDA records 6 decisions for Raumedic AG (Helmbrechts, DE) from 2011 to 2025: 6 510(k) clearances. All are in product code GWM (Device, Monitoring, Intracranial Pressure). Its devices cite 17 predicates, 10 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 Raumedic AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2011: 22012: 12013: 12017: 12025: 1
2011high 2 (2011) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Raumedic AG by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GWMDevice, Monitoring, Intracranial Pressure6decisions

Whose devices does it build on?

Its devices cite 17 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 10 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.

  • K103206Raumedic- Icp-Monitoring SystemRaumedic AG · 20114cite it
  • K130529Raumedic-Pto-Monitoring-SystemRaumedic AG · 20133cite it
  • K120252Raumedic-Icp-Temp-Monitoring-SystemRaumedic AG · 20123cite it
  • K112017Raumedic Icp Monitoring SystemRaumedic AG · 20112cite it

What has FDA decided for it lately?

  • K250285Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003); Neurovent-Ifd-S…Raumedic AG · 2025
  • K171666MPR2 logO DATALOGGERRaumedic AG · 2017
  • K130529Raumedic-Pto-Monitoring-SystemRaumedic AG · 2013
  • K120252Raumedic-Icp-Temp-Monitoring-SystemRaumedic AG · 2012
  • K112017Raumedic Icp Monitoring SystemRaumedic AG · 2011
  • K103206Raumedic- Icp-Monitoring SystemRaumedic AG · 2011

All 6 as Raumedic AG →