# Hemosonics, LLC

- Location (FDA's records): Durham, NC
- FDA decisions: 8 (2019–2025): 7 510(k) clearances and 1 De Novo grant
- Product codes: QFR (8)
- Predicates its devices cite: 9 (7 its own); citations of its devices by later devices: 7 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Pentapharm, Ltd.: 1 (https://510kreport.com/company/pentapharm)
- Tem Innovations GmbH: 1 (https://510kreport.com/company/tem-innovations)

## Its most-cited devices
- K213917: QStat Cartridge (2022), cited by 2
- DEN180017: Quantra Hemostasis Analyzer, QPlus Cartridge (2019), cited by 2
- K240045: QStat Cartridge (2024), cited by 1
- K230461: Quantra Hemostasis Analyzer (2023), cited by 1
- K223433: Quantra QPlus System (2022), cited by 1

## Recent decisions
- K251404: Quantra QStat Cartridge (Aug 25, 2025)
- K240045: QStat Cartridge (Mar 27, 2024)
- K232215: Quantra Hemostasis Analyzer (Aug 24, 2023)
- K230461: Quantra Hemostasis Analyzer (Mar 24, 2023)
- K223433: Quantra QPlus System (Dec 13, 2022)
- K213917: QStat Cartridge (Nov 29, 2022)
- K201513: Quantra QPlus System (Aug 21, 2020)
- DEN180017: Quantra Hemostasis Analyzer, QPlus Cartridge (Mar 12, 2019)

Source page: https://510kreport.com/company/hemosonics