# Brainscope Company, Inc.

- Location (FDA's records): Bethesda, MD
- FDA decisions: 8 (2009–2019): 7 510(k) clearances and 1 De Novo grant
- Product codes: PIW (7), OLT (1)
- Predicates its devices cite: 13 (6 its own); citations of its devices by later devices: 10 (6 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
- Vista Lifesciences, Inc.: 2 (https://510kreport.com/company/vista-lifesciences)
- Nxlink, Ltd.: 1 (https://510kreport.com/company/nxlink)
- Nicolet Biomedical, Inc.: 1 (https://510kreport.com/company/nicolet-biomedical)
- Cleveland Medical Devices, Inc.: 1 (https://510kreport.com/company/cleveland-medical-devices)
- Brainz Instruments, Ltd.: 1 (https://510kreport.com/company/brainz-instruments)
- Infinite Biomedical Technologies, LLC: 1 (https://510kreport.com/company/infinite-biomedical-technologies)

## Firms that cite its devices most
- Headsafe Mfg Pty, Ltd.: 1 (https://510kreport.com/company/headsafe-mfg)
- Jordan Neuroscience, Inc.: 1 (https://510kreport.com/company/jordan-neuroscience)
- Nihon Kohden America, Inc.: 1 (https://510kreport.com/company/nihon-kohden-america)
- Neurowave Systems, Inc.: 1 (https://510kreport.com/company/neurowave-systems)

## Its most-cited devices
- K082886: Zoom-100DC (2009), cited by 3
- K181179: BrainScope One (2018), cited by 2
- K143643: Brainscope Ahead 200 (2015), cited by 1
- K161068: Ahead 300 (2016), cited by 1
- DEN140025: BrainScope Ahead 100 (2014), cited by 1
- K183241: BrainScope TBI (Model: Ahead 400) (2019), cited by 1

## Recent decisions
- K190815: BrainScope TBI (Sep 11, 2019)
- K183241: BrainScope TBI (Model: Ahead 400) (Feb 19, 2019)
- K181785: Modified BrainScope One (Dec 19, 2018)
- K181179: BrainScope One (May 18, 2018)
- K161068: Ahead 300 (Sep 22, 2016)
- K143643: Brainscope Ahead 200 (May 15, 2015)
- DEN140025: BrainScope Ahead 100 (Nov 17, 2014)
- K082886: Zoom-100DC (Aug 10, 2009)

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