# Saranas, Inc.

- Location (FDA's records): Houston, TX
- FDA decisions: 2 (2019–2023): 1 510(k) clearance and 1 De Novo grant
- Product codes: QFJ (2)
- Predicates its devices cite: 1 (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

## Its most-cited devices
- DEN180021: Early Bird Bleed Monitoring System (2019), cited by 1

## Recent decisions
- K230273: Saranas Early Bird Bleed Monitoring System (May 25, 2023)
- DEN180021: Early Bird Bleed Monitoring System (Mar 1, 2019)

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