Class Class II
Wearable breast pump (model S12A) (K243508)
Description
Wearable breast pump (model S12A) by Shenzhen TPH Technology Co., Ltd., an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243508
Clearance Date2025-04-21
Clearance TypeAbbreviated
Product CodeHGX
Regulation Number884.5160
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243508
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. Wearable breast pump (model S12A) (K243508) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213311 | Lucy Breast Pump | Willow Innovations, Inc. | 2022 |
Trace the full predicate network for K243508
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.