# Zenflow, Inc.

- Location (FDA's records): South San Francisco, CA
- FDA decisions: 2 (2025–2025): 1 510(k) clearance and 1 original PMA approval
- Product codes: FAJ (1), MER (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
- Ambu A/S: 1 (https://510kreport.com/company/ambu-a-s)

## Recent decisions
- P250007: Zenflow Spring® Implant and Delivery System (Dec 11, 2025)
- K251140: Zenflow Spring Scope (Sep 23, 2025)

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