# I2s Micro Implantable Systems, LLC

- Location (FDA's records): Stoughton, WI
- FDA decisions: 1 (2009–2009): 1 510(k) clearance
- Product codes: GWL (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cyberkinetics, Inc.: 1 (https://510kreport.com/company/cyberkinetics)
- G.Tec Medical Engineering GmbH: 1 (https://510kreport.com/company/g-tec-medical-engineering)
- Eb Neuro S.P.A.: 1 (https://510kreport.com/company/eb-neuro)

## Firms that cite its devices most
- Blackrock Microsystems: 1 (https://510kreport.com/company/blackrock-microsystems)
- Carefusion 209, Inc.: 1 (https://510kreport.com/company/carefusion-209)
- Blackrock Neuromed: 1 (https://510kreport.com/company/blackrock-neuromed)

## Its most-cited devices
- K090957: Blackrock Neuroport Biopotential Signal Processing System (2009), cited by 3

## Recent decisions
- K090957: Blackrock Neuroport Biopotential Signal Processing System (May 28, 2009)

Source page: https://510kreport.com/company/i2s-micro-implantable-systems