Class Class II
Digital Routines (K221924)
Description
Digital Routines by Gnc Holdings, LLC, an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221924
Clearance Date2023-03-15
Clearance TypeTraditional
Product CodeNDC
Regulation Number868.1890
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221924
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Digital Routines (K221924) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203434 | BlueStar Rx | Welldoc, Inc. | 2021 |
Trace the full predicate network for K221924
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.