Class Class II
BioButton System (K241101)
Description
BioButton System by Biointellisense, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241101
Clearance Date2024-09-26
Clearance TypeTraditional
Product CodeDRG
Regulation Number870.2910
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241101
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. BioButton System (K241101) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212957 | BioButton System | Biolntellisense, Inc. | 2022 |
| K172586 | Vios Monitoring System™ Model 2050 | Vios Medical, Inc. | 2018 |
Trace the full predicate network for K241101
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.