Hi bebe super (BT-150B)
FDA 510(k) K251512 · Bistos Co., Ltd.
510(k) numberK251512
Submission
- Device name
- Hi bebe super (BT-150B)
- Applicant
- Bistos Co., Ltd.
Seongnam-Si, KR - Received
- May 16, 2025
- Decision date
- September 25, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HGX – Pump, Breast, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5160
- Specialty
- Obstetrics/Gynecology
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| K254254 | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)HGX · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 06/18/2026SE |
| K260538 | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )HGX · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 06/17/2026SE |
More from Shenzhen Root Innovation Technology Co., Ltd.
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|---|---|---|
| K232991 | BT-1000QGL · Traditional | 08/28/2024SE |
| K210289 | Infant Phototherapy EquipmentLBI · Traditional | 05/28/2021SE |
| K200675 | Hi bebe super (Models BT-150S and BT-150L)HGX · Special | 02/10/2021SE |
| K160274 | Hi bebe plusHGX · Traditional | 09/01/2016SE |
| K142799 | Model BT-220L and BT-220CHGM · Traditional | 07/09/2015SE |
| K132543 | Infant IncubatorFMZ · Traditional | 07/03/2014SE |
| K121267 | BT-200V Vascular DopplerHGM · Traditional | 08/02/2012SE |
| K103545 | BT-350HGM · Traditional | 05/13/2011SE |
| K100885 | Fetal Monitor Model: BT-200THGM · Traditional | 06/07/2010SE |
| K052190 | Fetal Monitor, Models BT-300 and BT-200HGM · Traditional | 10/04/2005SE |
Questions and answers
When was Hi bebe super (BT-150B) cleared by the FDA?
Hi bebe super (BT-150B) (K251512) received a 510(k) decision of Substantially Equivalent on September 25, 2025, 132 days after the submission was received.
What is the product code of K251512?
The FDA product code is HGX – Pump, Breast, Powered, a Class II (moderate risk) device regulated under 21 CFR 884.5160.