QVO · Class II · 21 CFR 882.5801

FDA Product Code QVO: Computerized Behavioral Therapy Device For Insomnia

The Device Is Intended To Provide Cognitive Behavioral Therapy To Treat Insomnia.

Leading manufacturers include Big Health, Inc..

2
Total
2
Cleared
272d
Avg days
2020
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Consistent review times: 272d avg (recent)

FDA 510(k) Cleared Computerized Behavioral Therapy Device For Insomnia Devices (Product Code QVO)

2 devices
1–2 of 2
Cleared Aug 05, 2024
Sleepio®
K233577
Big Health, Inc.
Neurology · 272d

About Product Code QVO - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code QVO since 2020, with 2 receiving FDA clearance (average review time: 272 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

FDA review times for QVO submissions have been consistent, averaging 272 days recently vs 271 days historically.

QVO devices are reviewed by the Neurology panel. Browse all Neurology devices →