Class Class II
Everion+ System (K213863)
Description
Everion+ System by Biofourmis Singapore Pte., Ltd., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK213863
Clearance Date2023-02-23
Clearance TypeTraditional
Product CodeMSX
Regulation Number870.2300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K213863
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. Everion+ System (K213863) cites 2 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K191620 | Vitls Platform | Vitls, Inc. | 2020 |
| K191272 | Wearable Device, Wearable Package | Current Health , Ltd. | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233418 | Biofourmis Everion+ (G2) | Biofourmis Singapore Pte., Ltd. | 2024 |
| K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica ... | Empatica S.r.l. | 2023 |
Trace the full predicate network for K213863
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.