Medical Device Manufacturer · US , Gainesville , FL

Xhale, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2015

Recent clearances: Nasal Alar SpO2 Sensor, Assurance Alar / Nasal SpO2 Sensor

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Xhale, Inc. Anesthesiology ✕

2 devices

1-2 of 2

Cleared Jul 27, 2017

Nasal Alar SpO2 Sensor

Anesthesiology · 73d

Cleared Mar 17, 2015

Assurance Alar / Nasal SpO2 Sensor

Anesthesiology · 127d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 14, 2026