# K260346: Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)

- Pathway: 510(k) (Traditional)
- Applicant: Polybell (Guangzhou) Limited
- Decided: Jun 12, 2026 after 129 days
- Product code: HGX (Pump, Breast, Powered)
- Device class: 2
- Regulation: 21 CFR 884.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K801862 (1980). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250843: Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B), Shenzhen TPH Technology Co., Ltd. (2025) Summary page 5.

## Indications for use
Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user.

Source page: https://510kreport.com/device/K260346
Methodology: https://510kreport.com/methodology