# Sandstone Diagnostics, Inc.

- Location (FDA's records): Livermore, CA
- FDA decisions: 2 (2016–2017): 2 510(k) clearances
- Product codes: POV (2)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 1 (1 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
- Princeton BioMeditech Corp.: 1 (https://510kreport.com/company/princeton-biomeditech)

## Its most-cited devices
- K153683: Trak Male Fertility Testing System (2016), cited by 1

## Recent decisions
- K172514: Trak Plus Male Fertility Testing System (Nov 17, 2017)
- K153683: Trak Male Fertility Testing System (May 16, 2016)

Source page: https://510kreport.com/company/sandstone-diagnostics