Class Class II
EnSite™ X EP System (K242016)
Description
EnSite™ X EP System by Abbott Medical, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242016
Clearance Date2024-08-09
Clearance TypeSpecial
Product CodeDQK
Regulation Number870.1425
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242016
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. EnSite™ X EP System (K242016) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231415 | EnSite X EP System | ABBOTT MEDICAL | 2023 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251234 | EnSite X EP System | ABBOTT MEDICAL | 2025 |
Trace the full predicate network for K242016
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.