FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
AViTA Breast Pump
K Number: K250129
·
Decision Jun 11, 2026
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
243
Applicant Total
27
Review Days
510
Basic Information
- Device Name
- AViTA Breast Pump
- K Number
- K250129
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Avita Corporation
- Date Received
- January 17, 2025
- Decision Date
- June 11, 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 |
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Other Clearances by Avita Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K252448 | AViTA Pulse Oximeter (SP61) | Feb 27, 2026 | Substantially Equivalent |
| K250765 | AViTA Arm Type Blood Pressure Monitor Cuff | Sep 3, 2025 | Substantially Equivalent |
| K242455 | AViTA Pulse Oximeter (SP62B) | Feb 19, 2025 | Substantially Equivalent |
| K241852 | Nasal Aspirator (NS 13) | Dec 31, 2024 | Substantially Equivalent |
| K242193 | Arm Type Blood Pressure Monitor (BPM82) | Oct 22, 2024 | Substantially Equivalent |
| K223399 | AViTA Pulse Oximeter | May 20, 2024 | Substantially Equivalent |
| K200346 | Wrist Type Blood Pressure Monitor | Dec 17, 2020 | Substantially Equivalent |
| K180155 | Arm Type Blood Pressure Monitor | Aug 3, 2018 | Substantially Equivalent |
| K172427 | AViTA Radar Thermo NT16 Series IR Thermometer | Apr 19, 2018 | Substantially Equivalent |
| K112825 | AVITA ARM TYPE BLOOD PRESSURE MONITOR | Jan 18, 2012 | Substantially Equivalent |