Class Class II
Zio® monitor (DFG0001) (K243650)
Description
Zio® monitor (DFG0001) by iRhythm Technologies, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243650
Clearance Date2025-08-15
Clearance TypeTraditional
Product CodeDSH
Regulation Number870.2800
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243650
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. Zio® monitor (DFG0001) (K243650) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240177 | Zio AT® device (A100A1001) | iRhythm Technologies, Inc. | 2024 |
| K202359 | Zio Monitor | iRhythm Technologies, Inc. | 2021 |
Trace the full predicate network for K243650
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.