510(k) Report

FDA applicant

Tem Innovations GmbH

Munich, Bavaria/Upper Bavaria, DE2 decisions2011–20225 recalls

FDA records 2 decisions for Tem Innovations GmbH (Munich, Bavaria/Upper Bavaria, DE) from 2011 to 2022: 2 510(k) clearances. All are in product code JPA (System, Multipurpose For In Vitro Coagulation…). Its devices cite 3 predicates, 1 of them its own earlier devices. 5 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

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

FDA decisions per year

1in 2022

2011: 12022: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

3in 2019

2014: 12016: 12019: 3
2011high 3 (2019) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Tem Innovations GmbH 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?

  • JPASystem, Multipurpose For In Vitro Coagulation Studies2decisions

Whose devices does it build on?

Its devices cite 3 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.

  • K101533EX-Tem. Fib-Tem, and AP-Tem for Rotem Delta Thromboelastometry SystemTem Innovations GmbH · 20112cite it

What has FDA decided for it lately?

  • K201440ROTEM sigma Thromboelastometry SystemTem Innovations GmbH · 2022
  • K101533EX-Tem. Fib-Tem, and AP-Tem for Rotem Delta Thromboelastometry SystemTem Innovations GmbH · 20115 recalls

All 2 as Tem Innovations GmbH →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K101533ROTEM ex-tem; US Part No: 503-05-USJul 23, 2019Class II
  • K101533ROTEM ex-tem Rest of the world part No: 503-05 (ROW)Jul 23, 2019Class II
  • K101533ROTEM ex-tem Canada Part No: 503-05-CAJul 23, 2019Class II
  • K101533ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem.…Sep 13, 2016Class II
  • K083842ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem…Oct 23, 2014Class II