# Radiometer Medical Aps

- Location (FDA's records): Bronshoj, DK
- FDA decisions: 28 (2004–2017): 28 510(k) clearances
- Product codes: CHL (13), JJS (3), MQM (2), LKD (2), JHX (2), CIG (1), JKA (1), JJY (1), CEM (1), CGL (1), KHO (1)
- Predicates its devices cite: 46 (23 its own); citations of its devices by later devices: 36 (23 its own)
- Recalls linked to its devices: 55 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Radiometer America, Inc.: 9 (https://510kreport.com/company/radiometer-america)
- Radiometer Medical A/S: 3 (https://510kreport.com/company/radiometer-medical-a-s)
- Roche Diagnostics Corp.: 2 (https://510kreport.com/company/roche-diagnostics)
- Fisher Diagnostics: 2 (https://510kreport.com/company/fisher-diagnostics)
- Bio-Rad: 2 (https://510kreport.com/company/bio-rad)
- Radiometer Basel AG: 1 (https://510kreport.com/company/radiometer-basel)
- Linde Medical Sensors AG: 1 (https://510kreport.com/company/linde-medical-sensors)
- Biomerieux Vitek, Inc.: 1 (https://510kreport.com/company/biomerieux-vitek)

## Firms that cite its devices most
- Radiometer Medicals Aps: 3 (https://510kreport.com/company/radiometer-medicals)
- Sendx Medical, Inc.: 2 (https://510kreport.com/company/sendx-medical)
- Siemens Healthcare Diagnostics, Inc.: 1 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Perimed, Inc.: 1 (https://510kreport.com/company/perimed)
- Siemens Medical Solutions Diagnostics: 1 (https://510kreport.com/company/siemens-medical-solutions-diagnostics)
- Sentec AG: 1 (https://510kreport.com/company/sentec)
- Instrumentation Laboratory CO: 1 (https://510kreport.com/company/instrumentation-laboratory)
- Opti Medical Systems, Inc.: 1 (https://510kreport.com/company/opti-medical-systems)

## Its most-cited devices
- K092686: ABL90 Flex Series (2010), cited by 6
- K041874: ABL800 Flex (2004), cited by 6
- K050869: Modification to ABL800 Flex (2005), cited by 4
- K043218: ABL800 Flex with Flexq Module, Model ABL8XX (2005), cited by 3
- K120197: ABL90 Flex (2012), cited by 2
- K093154: TCM Tosca Monitoring System, TCM Combim Monitoring System (2010), cited by 2

## Recent decisions
- K163462: AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX (Sep 21, 2017)
- K170882: ABL90 Flex, ABL90 Flex Plus (Apr 28, 2017)
- K160153: ABL90 Flex Plus (Nov 4, 2016)
- K142898: ABL800 FLEX with AQURE connectivity (Jun 17, 2015)
- K150226: Hematocrit and Metabolite QUALICHECK (May 13, 2015)
- K132691: ABL90 Flex (Nov 13, 2014)
- K131988: ABL90 Flex Analyzer (Sep 17, 2013)
- K130144: ABL90 Flex (Jul 31, 2013)

Source page: https://510kreport.com/company/radiometer-medical