Class Class II
Sonicaid Team3 (K250777)
Description
Sonicaid Team3 by Huntleigh Healthcare , Ltd., an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250777
Clearance Date2025-09-19
Clearance TypeTraditional
Product CodeHGM
Regulation Number884.2740
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250777
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. Sonicaid Team3 (K250777) cites 0 predicate devices and is itself cited by 1 later device.
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K253021 | ANNE Maternal | Sibel Health, Inc. | 2026 |
Trace the full predicate network for K250777
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.