# Carefusion 209, Inc.

- Location (FDA's records): Middleton, WI
- FDA decisions: 5 (2011–2012): 5 510(k) clearances
- Product codes: GWF (2), IKT (2), GWL (1)
- Predicates its devices cite: 19 (1 its own); citations of its devices by later devices: 14 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medelec, Ltd.: 2 (https://510kreport.com/company/medelec)
- Nicolet Biomedical, Inc.: 2 (https://510kreport.com/company/nicolet-biomedical)
- Nihon Kohden America, Inc.: 2 (https://510kreport.com/company/nihon-kohden-america)
- Nicolet Instrument Corp.: 1 (https://510kreport.com/company/nicolet-instrument)
- Oxford Instruments Medical Systems: 1 (https://510kreport.com/company/oxford-instruments-medical-systems)
- Teleemg, LLC USA: 1 (https://510kreport.com/company/teleemg-usa)
- Cadwell Laboratories, Inc.: 1 (https://510kreport.com/company/cadwell-laboratories)
- Medelec Intl. Corp.: 1 (https://510kreport.com/company/medelec-intl)

## Firms that cite its devices most
- Natus Neurology Incorporated: 3 (https://510kreport.com/company/natus-neurology)
- Cadwell Industries, Inc.: 2 (https://510kreport.com/company/cadwell-industries)
- Neuroelectrics Barcelona S.L.U.: 1 (https://510kreport.com/company/neuroelectrics-barcelona-slu)
- Mobilemedtek: 1 (https://510kreport.com/company/mobilemedtek)
- Technomed Europe: 1 (https://510kreport.com/company/technomed-europe)
- Natus Manufacturing Limited: 1 (https://510kreport.com/company/natus-manufacturing)
- Evoke Neuroscience, Inc.: 1 (https://510kreport.com/company/evoke-neuroscience)
- Lifelines, Ltd.: 1 (https://510kreport.com/company/lifelines)

## Its most-cited devices
- K112052: Carefusion Nicolet Edx (2012), cited by 4
- K120979: Carefusion Nicolet Edx (2012), cited by 4
- K103140: Nicolet Wireless Eeg (2011), cited by 4
- K112034: Teca Elite Disposable Concentric Needles (2011), cited by 2

## Recent decisions
- K120979: Carefusion Nicolet Edx (Apr 25, 2012)
- K112052: Carefusion Nicolet Edx (Mar 15, 2012)
- K112034: Teca Elite Disposable Concentric Needles (Aug 12, 2011)
- K111131: Teca (TM) Elite Disposable Monopolar Needles (Jun 17, 2011)
- K103140: Nicolet Wireless Eeg (Apr 8, 2011)

Source page: https://510kreport.com/company/carefusion-209