510(k) Report

FDA applicant

Moller Medical GmbH

Fulda, DE3 decisions2013–20170 recalls

FDA records 3 decisions for Moller Medical GmbH (Fulda, DE) from 2013 to 2017: 3 510(k) clearances. Most are in product codes JXG (Shunt, Central Nervous System And Components) and KNW (Instrument, Biopsy). Its devices cite 13 predicates, 1 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 Moller Medical GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2013: 12015: 12017: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Moller Medical GmbH by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JXGShunt, Central Nervous System And Components2decisions
  • KNWInstrument, Biopsy1decision

Whose devices does it build on?

Its devices cite 13 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K162588Möller Medical Biopsy Needles and SystemsMoller Medical GmbH · 20171cites it
  • K121248Liquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF Tubing Set (2000MM) Safety Cushion for…Moller Medical GmbH · 20131cites it

What has FDA decided for it lately?

  • K162588Möller Medical Biopsy Needles and SystemsMoller Medical GmbH · 2017
  • K150898LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mmMoller Medical GmbH · 2015
  • K121248Liquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF Tubing Set (2000MM) Safety Cushion for…Moller Medical GmbH · 2013

All 3 as Moller Medical GmbH →