FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Hi bebe super (BT-150B)
K Number: K251512
·
Decision Sep 25, 2025
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
243
Applicant Total
11
Review Days
132
Basic Information
- Device Name
- Hi bebe super (BT-150B)
- K Number
- K251512
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 884.5160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bistos Co., Ltd.
- Date Received
- May 16, 2025
- Decision Date
- September 25, 2025
- Product Code
- HGX
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HGX | Pump, Breast, Powered | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Bistos Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K232991 | BT-1000 | Aug 28, 2024 | Substantially Equivalent |
| K210289 | Infant Phototherapy Equipment | May 28, 2021 | Substantially Equivalent |
| K200675 | Hi bebe super (Models BT-150S and BT-150L) | Feb 10, 2021 | Substantially Equivalent |
| K160274 | Hi bebe plus | Sep 1, 2016 | Substantially Equivalent |
| K142799 | Model BT-220L and BT-220C | Jul 9, 2015 | Substantially Equivalent |
| K132543 | INFANT INCUBATOR | Jul 3, 2014 | Substantially Equivalent |
| K121267 | BT-200V VASCULAR DOPPLER | Aug 2, 2012 | Substantially Equivalent |
| K103545 | BT-350 | May 13, 2011 | Substantially Equivalent |
| K100885 | FETAL MONITOR MODEL: BT-200T | Jun 7, 2010 | Substantially Equivalent |
| K052190 | FETAL MONITOR, MODELS BT-300 AND BT-200 | Oct 4, 2005 | Substantially Equivalent |