# K200675: Hi bebe super (Models BT-150S and BT-150L)

- Pathway: 510(k) (Special)
- Applicant: Bistos Co., Ltd.
- Decided: Feb 10, 2021 after 331 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: 7 generations back to K801862 (1980). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160274: Hi bebe plus, Bistos Co., Ltd. (2016) Summary page 4.

## Most influential descendants
- K251512: Hi bebe super (BT-150B) (2025), 0 descendants of its own
- K211016: Powered Breast Pump (Models 7V and 7X) (2022), 0 descendants of its own

## Indications for use
Hi bebe super (Models BT-150S and BT-150L) is intended to be used by lactating women for expressing and collecting breast milk. It is intended for a single user.

Source page: https://510kreport.com/device/K200675
Methodology: https://510kreport.com/methodology