# Sonex Health, Inc.

- Location (FDA's records): Rochester, MN
- FDA decisions: 2 (2019–2025): 2 510(k) clearances
- Names in FDA's records: Sonex Health, Inc. (1); Sonex Health (1)
- Product codes: LXH (1), HRX (1)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (1 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
- Orthomet, Inc.: 1 (https://510kreport.com/company/orthomet)
- Microaire Surgical Instruments, LLC: 1 (https://510kreport.com/company/microaire-surgical-instruments)

## Its most-cited devices
- K192873: SX-One MicroKnife (2019), cited by 1

## Recent decisions
- K252594: UltraGuideCTR® image guided soft tissue release system (Sep 29, 2025)
- K192873: SX-One MicroKnife (Dec 20, 2019)

Source page: https://510kreport.com/company/sonex-health