# Spirosure, Inc.

- Location (FDA's records): Pleasanton, CA
- FDA decisions: 1 (2019–2019): 1 510(k) clearance
- Product codes: MXA (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Aerocrine AB: 1 (https://510kreport.com/company/aerocrine)

## Firms that cite its devices most
- Caire Diagnostics, Inc.: 1 (https://510kreport.com/company/caire-diagnostics)

## Its most-cited devices
- K182874: Fenom Pro Nitric Oxide Test (2019), cited by 1

## Recent decisions
- K182874: Fenom Pro Nitric Oxide Test (Feb 13, 2019)

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