Class Class II
ZEUS System (K222389)
Description
ZEUS System by iRhythm Technologies, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222389
Clearance Date2023-02-15
Clearance TypeTraditional
Product CodeDQK
Regulation Number870.1425
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222389
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. ZEUS System (K222389) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202527 | Zio ECG Utilization Software (ZEUS) System | iRhythm Technologies, Inc. | 2021 |
Trace the full predicate network for K222389
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.