Genadyne A4 Powered Suction Pump
FDA 510(k) K080745 · Genadyne Biotechnologies, Inc.
510(k) numberK080745
Submission
- Device name
- Genadyne A4 Powered Suction Pump
- Applicant
- Genadyne Biotechnologies, Inc.
Great Neck, NY, US - Received
- March 17, 2008
- Decision date
- July 30, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTA – Pump, Portable, Aspiration (Manual Or Powered)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code BTA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253629 | Momcozy Nasal Aspirator (BN007)BTA · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 05/26/2026SE |
| K260134 | Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A…BTA · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 05/15/2026SE |
| K260892 | Suction Pump (SU-90)BTA · Traditional | Shenzhen HugeMed Medical Technical Development… | 05/14/2026SE |
| K260473 | Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)BTA · Traditional | Shenzhen Kingboom Technology Co., Ltd. | 05/12/2026SE |
| K253107 | Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)BTA · Traditional | Shenzhen Dongjiang Technology Co., Ltd. | 04/14/2026SE |
| K260147 | Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)BTA · Traditional | Shenzhen Kingboom Technology Co., Ltd. | 03/13/2026SE |
| K251450 | Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator…BTA · Special | Shenzhen Desida Technology Co., Ltd. | 06/06/2025SE |
| K244033 | Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)BTA · Traditional | Shenzhen Desida Technology Co., Ltd. | 05/16/2025SE |
| K251101 | AIRO Suction Unit (AIRO-01)BTA · Traditional | Cro, LLC | 04/26/2025SE |
| K250697 | Electric Nasal Aspirator (BC026, BC025, BC023)BTA · Traditional | Shenzhen Kingboom Technology Co., Ltd. | 04/23/2025SE |
More from Shenzhen Kingboom Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253429 | Genadyne ASTRA NPWTOMP · Traditional | 03/12/2026SE |
| K243225 | Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes…BZD · Special | 12/31/2024SE |
| K233614 | Genadyne DUO NPWTOMP · Traditional | 12/23/2024SE |
| K221888 | Genadyne Hybrid Foam DressingsOMP · Traditional | 06/12/2023SE |
| K221891 | UNO Negative Pressure Wound Therapy SystemOMP · Special | 12/14/2022SE |
| K210107 | Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy SystemOMP · Traditional | 06/01/2022SE |
| K190028 | Uno 30OMP · Traditional | 01/15/2020SE |
| K182722 | XLR8 Abdominal Wound Dressing KitOMP · Traditional | 09/27/2019SE |
| K180840 | UNO Negative Pressure Wound Therapy SystemOMP · Traditional | 11/30/2018SE |
| K161599 | UNO Negative Pressure Wound Therapy SystemOMP · Traditional | 04/06/2017SE |
Questions and answers
When was Genadyne A4 Powered Suction Pump cleared by the FDA?
Genadyne A4 Powered Suction Pump (K080745) received a 510(k) decision of Substantially Equivalent on July 30, 2008, 135 days after the submission was received.
What is the product code of K080745?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.