Class Class II

Momcozy Wearable Breast Pump (BP223) (K251394)

K251394 2025-09-08 Traditional
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Description

Momcozy Wearable Breast Pump (BP223) by Shenzhen Root Innovation Technology Co., Ltd., an FDA 510(k) cleared obstetrics/gynecology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251394
Clearance Date2025-09-08
Clearance TypeTraditional
Product CodeHGX
Regulation Number884.5160

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Predicate lineage for K251394

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. Momcozy Wearable Breast Pump (BP223) (K251394) cites 0 predicate devices and is itself cited by 1 later device.

Later devices that cite this one as their predicate

Devices that cite K251394
K numberDeviceApplicantYear
K253934Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP38...Shenzhen Root Innovation Technology...2026

Trace the full predicate network for K251394

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.

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