FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Genadyne ASTRA NPWT
K Number: K253429
·
Decision Mar 12, 2026
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
211
Applicant Total
19
Review Days
162
Basic Information
- Device Name
- Genadyne ASTRA NPWT
- K Number
- K253429
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genadyne Biotechnologies, Inc.
- Date Received
- October 1, 2025
- Decision Date
- March 12, 2026
- Product Code
- OMP
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Genadyne Biotechnologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243225 | Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) | Dec 31, 2024 | Substantially Equivalent |
| K233614 | Genadyne DUO NPWT | Dec 23, 2024 | Substantially Equivalent |
| K221888 | Genadyne Hybrid Foam Dressings | Jun 12, 2023 | Substantially Equivalent |
| K221891 | UNO Negative Pressure Wound Therapy System | Dec 14, 2022 | Substantially Equivalent |
| K210107 | Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System | Jun 1, 2022 | Substantially Equivalent |
| K180840 | UNO Negative Pressure Wound Therapy System | Nov 30, 2018 | Substantially Equivalent |
| K161599 | UNO Negative Pressure Wound Therapy System | Apr 6, 2017 | Substantially Equivalent |
| K143726 | XLR8 PLUS (XLR8+) | Jun 19, 2015 | Substantially Equivalent |
| K142646 | XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and | Apr 30, 2015 | Substantially Equivalent |
| K143574 | Melodi Prime Breast Pump | Apr 21, 2015 | Substantially Equivalent |