# Xhale, Inc.

- Location (FDA's records): Gainesville, FL
- FDA decisions: 3 (2013–2017): 3 510(k) clearances
- Names in FDA's records: Xhale, Inc. (2); Xhale (1)
- Product codes: DQA (3)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 3 (2 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
- Nellcor Puritan Bennett, Inc.: 3 (https://510kreport.com/company/nellcor-puritan-bennett)
- Masimo Corporation: 1 (https://510kreport.com/company/masimo)

## Firms that cite its devices most
- Philips Medizin Systeme: 1 (https://510kreport.com/company/philips-medizin-systeme)

## Its most-cited devices
- K122996: Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085 (2013), cited by 1
- K143216: Assurance Alar / Nasal SpO2 Sensor (2015), cited by 1
- K171423: Nasal Alar SpO2 Sensor (2017), cited by 1

## Recent decisions
- K171423: Nasal Alar SpO2 Sensor (Jul 27, 2017)
- K143216: Assurance Alar / Nasal SpO2 Sensor (Mar 17, 2015)
- K122996: Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085 (Apr 10, 2013)

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