Class Class II
Hailie Sensor NF0110 (K222247)
Description
Hailie Sensor NF0110 by Adherium (Nz), Ltd., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222247
Clearance Date2023-02-08
Clearance TypeTraditional
Product CodeCAF
Regulation Number868.5630
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222247
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. Hailie Sensor NF0110 (K222247) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211233 | Hailie Sensor NF0109 | Adherium (Nz), Ltd. | 2021 |
| K180407 | Smartinhaler | Adherium (Nz), Ltd. | 2018 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250022 | HeroTracker Sense | Voluntis | 2025 |
Trace the full predicate network for K222247
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.