Hi bebe plus
FDA 510(k) K160274 · Bistos Co., Ltd.
510(k) numberK160274
Submission
- Device name
- Hi bebe plus
- Applicant
- Bistos Co., Ltd.
Seongnam-Si, KR - Received
- February 2, 2016
- Decision date
- September 1, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
Other 510(k)s with product code HGX
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|---|---|---|---|
| K261622 | Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52…HGX · Traditional | Philips Consumer Lifestyle B.V. | 09/03/2026SE |
| K262774 | Wearable breast pump (Model: XN/MD-2249BS, ZFHF)HGX · Traditional | Guangdong Horigen Mother & Baby Products Co., Ltd. | 09/01/2026SE |
| K260643 | Cimilre Dual MaxHGX · Traditional | Cimilre Co., Ltd. | 08/21/2026SE |
| K261298 | Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))HGX · Traditional | Guangdong Youmeng Electrical Technology Co., Ltd. | 08/20/2026SE |
| K260259 | DiscreetDuo Flow Wearable Breast Pump (Model S3)HGX · Traditional | Shenzhen TPH Technology Co., Ltd. | 07/24/2026SE |
| K261199 | Wearable Breast Pump (Model S32A)HGX · Traditional | Shenzhen TPH Technology Co., Ltd. | 07/13/2026SE |
| K250070 | Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)HGX · Traditional | Shenzhen Changkun Technology Co., Ltd. | 06/26/2026SE |
| K261025 | Wearable breast pump (QY-101, QY-102, QY-108)HGX · Traditional | Shenzhen Qinyi Electronic Technology Co., Ltd. | 06/25/2026SE |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K251512 | Hi bebe super (BT-150B)HGX · Special | 09/25/2025SE |
| 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 |
| 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 plus cleared by the FDA?
Hi bebe plus (K160274) received a 510(k) decision of Substantially Equivalent on September 1, 2016, 212 days after the submission was received.
What is the product code of K160274?
The FDA product code is HGX – Pump, Breast, Powered, a Class II (moderate risk) device regulated under 21 CFR 884.5160.