FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Hi bebe super (Models BT-150S and BT-150L)
K Number: K200675
·
Decision Feb 10, 2021
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
243
Applicant Total
11
Review Days
331
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Hi bebe super (Models BT-150S and BT-150L)
- K Number
- K200675
- 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
- March 16, 2020
- Decision Date
- February 10, 2021
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HGX), ordered by most recent decision date.
Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AViTA Breast Pump
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Mother's Nature W1 Warming Wearable Breast Pump
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Spectra Platinum Mini
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Bistos Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K251512 | Hi bebe super (BT-150B) | Sep 25, 2025 | Substantially Equivalent |
| K232991 | BT-1000 | Aug 28, 2024 | Substantially Equivalent |
| K210289 | Infant Phototherapy Equipment | May 28, 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 |