FDA Product Code QDB: Photoplethysmograph Analysis Software For Over-the-counter Use
A Photoplethysmograph Analysis Software Device For Over-the-counter Use Analyzes Photoplethysmograph Data And Provides Information For Identifying Irregular Heart Rhythms. This Device Is Not Intended To Provide A Diagnosis.
Leading manufacturers include Apple, Inc. and Fitbit, Inc..
5
Total
4
Cleared
122d
Avg days
2018
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Photoplethysmograph Analysis Software For Over-the-counter Use Devices (Product Code QDB)
5 devices
Cleared
Jul 21, 2023
Irregular Rhythm Notification Feature (IRNF)
Apple, Inc.
Cardiovascular
87d
Cleared
Jun 03, 2022
Atrial Fibrillation History Feature
Apple, Inc.
Cardiovascular
165d
Cleared
Apr 08, 2022
Fitbit Irregular Rhythm Notifications
Fitbit, Inc.
Cardiovascular
252d
Cleared
Oct 22, 2021
IRNF App
Apple, Inc.
Cardiovascular
73d
Not Cleared
Sep 11, 2018
Irregular Rhythm Notification Feature
Apple, Inc.
Cardiovascular
33d
About Product Code QDB - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code QDB since 2018, with 4 receiving FDA clearance (average review time: 122 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.