Class Class II
Biobeat Platform-2 and BB-613WP Patch (K222010)
Description
Biobeat Platform-2 and BB-613WP Patch by Biobeat Technologies , Ltd., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222010
Clearance Date2022-12-30
Clearance TypeTraditional
Product CodeDQA
Regulation Number870.2700
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222010
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. Biobeat Platform-2 and BB-613WP Patch (K222010) cites 2 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212153 | Biobeat Platform, BB-613WP Patch | Biobeat Technologies , Ltd. | 2022 |
| K182245 | EV1000 Clinical Platform Non-Invasive (NI) with ClearSight ... | Edwards Lifesciences, LLC | 2018 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250934 | Respiree Cardio- Respiratory Monitor System | Respiree Pte, Ltd. | 2025 |
| K241066 | BB-613-BPM | Biobeat Technologies , Ltd. | 2025 |
Trace the full predicate network for K222010
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.