# Sphere Medical, Ltd.

- Location (FDA's records): Cambridge, GB
- FDA decisions: 1 (2011–2011): 1 510(k) clearance
- Product codes: CGA (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 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
- Ciba Corning Diagnostics Corp.: 1 (https://510kreport.com/company/ciba-corning-diagnostics)

## Recent decisions
- K101947: IVD-GE02 (Mar 16, 2011)

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