Class Class II
ANNE View, Central Hub (K242842)
Description
ANNE View, Central Hub by Sibel Health, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242842
Clearance Date2025-01-08
Clearance TypeTraditional
Product CodeMSX
Regulation Number870.2300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242842
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. ANNE View, Central Hub (K242842) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223711 | ANNE One | Sibel Health, Inc. | 2023 |
| K202497 | Aulisa Multiple Patient Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Techn... | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243837 | iBSM | Iorbit Digital Technologies Private... | 2025 |
Trace the full predicate network for K242842
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.