Hi bebe Super (BT-150B)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K251512 FDA 510(k)
- FDA Product Code
- HGX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.5160 FDA 510(k)
- Regulation Number
- 884.5160 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Hi bebe Super (BT-150B) is a Powered Breast Pump, designed to assist in the expression of breast milk for lactating individuals. It operates as a mechanical device to create suction, facilitating efficient milk removal for feeding or storage purposes.
This device is intended for use in obstetrics and gynecology settings, supplied as a reusable unit. It has received FDA 510K clearance and complies with the Medical Device Directive (MDD). The BT-150B model is classified under Class II and is regulated under the EU registration number 884.5160. No specific sterility or MRI safety information is provided in the data.
Frequently asked questions
Is the Hi bebe Super (BT-150B) designed for single-use or can it be reused over multiple sessions?
The Hi bebe Super (BT-150B) is explicitly described as a reusable unit, meaning it is intended for repeated use across multiple sessions by the same or different lactating individuals. Since it is classified as a reusable device, proper cleaning and maintenance per manufacturer guidelines are essential to ensure safe and effective operation.
What regulatory pathways has the Hi bebe Super (BT-150B) followed for approval, and where is it currently authorized?
The Hi bebe Super (BT-150B) has received FDA 510K clearance and complies with the Medical Device Directive (MDD) in the EU, with an EU registration number 884.5160. This indicates it is authorized for commercial distribution in both the U.S. and European markets under these regulatory frameworks. The device is classified as Class II in the EU.
Are there specific storage requirements for the Hi bebe Super (BT-150B) to maintain its performance and safety?
The provided data does not explicitly detail storage requirements such as temperature, humidity, or shelf life. However, since it is a reusable mechanical device, it should be stored in a clean, dry environment when not in use to prevent contamination or damage. Always follow the manufacturer’s instructions for optimal care and longevity.
What medical specialty is the Hi bebe Super (BT-150B) primarily associated with, and how is it intended to be used?
The Hi bebe Super (BT-150B) is intended for use in obstetrics and gynecology settings, specifically as a powered breast pump to assist lactating individuals in expressing breast milk. It is designed to create suction mechanically, facilitating efficient milk removal for feeding or storage purposes. The device’s regulatory filing under the Obstetrics/Gynecology advisory committee reflects its clinical application.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K251512 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bistos Co., Ltd.
Sources (2)
- FDA 510(k) K251512 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026