# Expanse Medical, Inc.

- Location (FDA's records): Pleasanton, CA
- FDA decisions: 3 (2024–2026): 3 510(k) clearances
- Product codes: QEZ (2), QEW (1)
- 510(k) review time since 2016: median 81 days, against 98 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 3 (2 its own); citations of its devices by later devices: 2 (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
- Penumbra, Inc.: 1 (https://510kreport.com/company/penumbra)

## Its most-cited devices
- K234073: ICE Aspiration System (2024), cited by 1
- K251488: FLOWRUNNER Aspiration System (2025), cited by 1

## Recent decisions
- K254208: FLOWRUNNER Aspiration System (Mar 20, 2026)
- K251488: FLOWRUNNER Aspiration System (Jul 14, 2025)
- K234073: ICE Aspiration System (Apr 19, 2024)

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