510(k) Report

FDA applicant

Somatex Medical Technologies GmbH

Cambridge, MA7 decisions2008–20211 recall

FDA records 7 decisions for Somatex Medical Technologies GmbH (Cambridge, MA) from 2008 to 2021: 7 510(k) clearances. Most are in product codes NEU (Marker, Radiographic, Implantable) and KNW (Instrument, Biopsy). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 6 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2021

2008: 12010: 12011: 22018: 22021: 1
2008high 2 (2011) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2008high 1 (2017) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Somatex Medical Technologies GmbH by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Somatex Medical Technologies GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NEUMarker, Radiographic, Implantable6decisions
  • KNWInstrument, Biopsy1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 90 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 89 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 6 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.

  • K073095Tumark Professional, Model 271560; MR- Tumark Professional, Model 601560Somatex Medical Technologies GmbH · 20084cite it
  • K093064Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560Somatex Medical Technologies GmbH · 20104cite it
  • K111692Tumark Flex for Mammotome,Tumark Flex for AtecSomatex Medical Technologies GmbH · 20112cite it

What has FDA decided for it lately?

  • K201863Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-ShapeSomatex Medical Technologies GmbH · 2021
  • K182082Tumark for Eviva, Tumark for BreveraSomatex Medical Technologies GmbH · 2018
  • K180443Tumark VisionSomatex Medical Technologies GmbH · 2018
  • K111692Tumark Flex for Mammotome,Tumark Flex for AtecSomatex Medical Technologies GmbH · 2011
  • K102771Biopsy Handy, Mri Biopsy HandySomatex Medical Technologies GmbH · 2011
  • K093064Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560Somatex Medical Technologies GmbH · 2010
  • K073095Tumark Professional, Model 271560; MR- Tumark Professional, Model 601560Somatex Medical Technologies GmbH · 20081 recall

All 7 as Somatex Medical Technologies GmbH →

What has been recalled?

1 recall linked to its devices; the latest:

  • K073095TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILEMay 22, 2017Class II