Class Class II
HeroTracker Sense (K250022)
Description
HeroTracker Sense by Voluntis, an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250022
Clearance Date2025-06-30
Clearance TypeTraditional
Product CodeCAF
Regulation Number868.5630
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250022
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. HeroTracker Sense (K250022) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222247 | Hailie Sensor NF0110 | Adherium (Nz), Ltd. | 2023 |
Trace the full predicate network for K250022
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.