FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GENADYNE A4 POWERED SUCTION PUMP
K Number: K080745
·
Decision Jul 30, 2008
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
158
Applicant Total
19
Review Days
135
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
- GENADYNE A4 POWERED SUCTION PUMP
- K Number
- K080745
- 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
- March 17, 2008
- Decision Date
- July 30, 2008
- Product Code
- BTA
- 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 |
|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTA), ordered by most recent decision date.
Momcozy Nasal Aspirator (BN007)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Suction Pump (SU-90)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Genadyne Biotechnologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253429 | Genadyne ASTRA NPWT | Mar 12, 2026 | Substantially Equivalent |
| 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 |