# Tem Innovations GmbH

- Location (FDA's records): Munich, Bavaria/Upper Bavaria, DE
- FDA decisions: 2 (2011–2022): 2 510(k) clearances
- Product codes: JPA (2)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Haemoscope Corp.: 1 (https://510kreport.com/company/haemoscope)
- Pentapharm, Ltd.: 1 (https://510kreport.com/company/pentapharm)

## Firms that cite its devices most
- Hemosonics, LLC: 1 (https://510kreport.com/company/hemosonics)

## Its most-cited devices
- K101533: EX-Tem. Fib-Tem, and AP-Tem for Rotem Delta Thromboelastometry System (2011), cited by 2

## Recent decisions
- K201440: ROTEM sigma Thromboelastometry System (Jul 8, 2022)
- K101533: EX-Tem. Fib-Tem, and AP-Tem for Rotem Delta Thromboelastometry System (Aug 10, 2011)

Source page: https://510kreport.com/company/tem-innovations