FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Spectra S1 Pro; Spectra S2 Pro
K Number: K251423
·
Decision Feb 6, 2026
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
243
Applicant Total
5
Review Days
274
Basic Information
- Device Name
- Spectra S1 Pro; Spectra S2 Pro
- K Number
- K251423
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Uzinmedicare Co., Ltd.
- Date Received
- May 8, 2025
- Decision Date
- February 6, 2026
- 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