# K241004: Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2)

- Pathway: 510(k) (Traditional)
- Applicant: Huizhou Lvb Maternal and Infant Supplies Co., Ltd.
- Decided: Sep 11, 2024 after 152 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)
- K230102: Smart double sides wearable breast pump, Electric bilateral breast pump, Huizhou Lvb Maternal and Infant Supplies Co., Ltd. (2023) Summary page 5.

## Indications for use
Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) 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/K241004
Methodology: https://510kreport.com/methodology