# Fifth Eye, Inc.

- Location (FDA's records): Ann Arbor, MI
- FDA decisions: 3 (2021–2022): 2 510(k) clearances and 1 De Novo grant
- Product codes: QNV (3)
- Predicates its devices cite: 3 (2 its own); citations of its devices by later devices: 3 (2 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
- Clew Medical, Ltd.: 1 (https://510kreport.com/company/clew-medical)

## Firms that cite its devices most
- The Surgeon General, Department of the Army (TSG-DA): 1 (https://510kreport.com/company/surgeon-general-department-of-the-army-tsg-da)

## Its most-cited devices
- DEN200022: Analytic for Hemodynamic Instability (AHI) (2021), cited by 2
- K212219: AHI System (2021), cited by 1

## Recent decisions
- K221203: AHI System (Jul 14, 2022)
- K212219: AHI System (Dec 3, 2021)
- DEN200022: Analytic for Hemodynamic Instability (AHI) (Mar 1, 2021)

Source page: https://510kreport.com/company/fifth-eye