# Radiometer America, Inc.

- Location (FDA's records): Westlake, OH
- FDA decisions: 50 (1983–2016): 50 510(k) clearances
- Product codes: CHL (15), JJS (9), JWY (5), JJY (2), DQA (2), JGS (2), LIE (1), CGA (1), CEM (1), JKS (1), GLY (1), CBT (1)
- Predicates its devices cite: 17 (12 its own); citations of its devices by later devices: 36 (12 its own)
- Recalls linked to its devices: 23 (9 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Maine Standards Co.: 1 (https://510kreport.com/company/maine-standards)
- Leica, Inc.: 1 (https://510kreport.com/company/leica)
- Advanced Instruments, Inc.: 1 (https://510kreport.com/company/advanced-instruments)
- Eastman Kodak Company: 1 (https://510kreport.com/company/eastman-kodak)
- Avl Scientific Corp.: 1 (https://510kreport.com/company/avl-scientific)

## Firms that cite its devices most
- Radiometer Medical Aps: 9 (https://510kreport.com/company/radiometer-medical)
- Masimo Corporation: 3 (https://510kreport.com/company/masimo)
- Sendx Medical, Inc.: 2 (https://510kreport.com/company/sendx-medical)
- Avl Scientific Corp.: 1 (https://510kreport.com/company/avl-scientific)
- Ge Medical Systems Information Technologies: 1 (https://510kreport.com/company/ge-medical-systems-information-technologies)
- Abaxis, Inc.: 1 (https://510kreport.com/company/abaxis)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Nir Diagnostics, Inc.: 1 (https://510kreport.com/company/nir-diagnostics)

## Its most-cited devices
- K980135: QUALICHECK5+ Models S7730, S7740, S7750, S7760 (1998), cited by 6
- K980130: ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite System (1998), cited by 4
- K853990: OSM3 Hemoximeter (1985), cited by 4
- K991417: Abl 735 Analyzer (1999), cited by 3
- K954612: Abl System 625, 615, 605 (1995), cited by 2
- K973367: ABL555 Blood Gas, Electrolyte & Metabolite System (1997), cited by 2

## Recent decisions
- K153712: VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit (Jan 28, 2016)
- K992859: ABL700 Series Analyzer with Autocheck Module (Jan 10, 2000)
- K991417: Abl 735 Analyzer (Nov 24, 1999)
- K982928: NPT7 Series PH/Blood Gas and CO-Oximetry System (Jan 6, 1999)
- K980130: ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite System (Feb 9, 1998)
- K980135: QUALICHECK5+ Models S7730, S7740, S7750, S7760 (Jan 28, 1998)
- K974818: ABL555 Blood Gas, Electrolyte & Metabolite System (Jan 16, 1998)
- K973367: ABL555 Blood Gas, Electrolyte & Metabolite System (Oct 6, 1997)

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