Class Class II
iBSM (K243837)
Description
iBSM by Iorbit Digital Technologies Private Limited, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243837
Clearance Date2025-05-16
Clearance TypeTraditional
Product CodeDRG
Regulation Number870.2910
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243837
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. iBSM (K243837) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242842 | ANNE View, Central Hub | Sibel Health, Inc. | 2025 |
| K240251 | ANNE Chest | Sibel Health, Inc. | 2024 |
| K223711 | ANNE One | Sibel Health, Inc. | 2023 |
| K193348 | Blood Pressure Monitor | Shenzhen Viatom Technology Co., Ltd. | 2020 |
Trace the full predicate network for K243837
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.