Class Class II
Zio AT® device (A100A1001) (K240177)
Description
Zio AT® device (A100A1001) by iRhythm Technologies, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240177
Clearance Date2024-10-30
Clearance TypeTraditional
Product CodeDSI
Regulation Number870.1025
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240177
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 AT® device (A100A1001) (K240177) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240029 | Zio AT® device (A100A1001) | iRhythm Technologies, Inc. | 2024 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243650 | Zio® monitor (DFG0001) | iRhythm Technologies, Inc. | 2025 |
Trace the full predicate network for K240177
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.