Smartsuction Solo Device
FDA 510(k) K062801 · Haemonetics Corp.
510(k) numberK062801
Submission
- Device name
- Smartsuction Solo Device
- Applicant
- Haemonetics Corp.
Braintree, MA, US - Received
- September 19, 2006
- Decision date
- October 4, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
|---|---|---|
| K251024 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeJPA · Special | 04/30/2025SE |
| K243858 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeJPA · Special | 01/15/2025SE |
| K232018 | Citrated: K, KH, RTH, FFHJPA · Traditional | 03/29/2024SE |
| K221722 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)CAC · Traditional | 11/15/2022SE |
| K183160 | TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay CartridgeJPA · Traditional | 05/09/2019SE |
| K160502 | TEG 6s Hemostasis SystemJPA · Special | 04/19/2017SE |
| K162423 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemCAC · Traditional | 01/03/2017SE |
| K160197 | Haemonetics Cell Saver Elite Autotransfusion SystemCAC · Traditional | 05/24/2016SE |
| K122262 | Orthopat Advance Perioperative Autotransfusion SystemCAC · Traditional | 10/25/2012SE |
| K120586 | Cell Saver EliteCAC · Traditional | 05/22/2012SE |
Questions and answers
When was Smartsuction Solo Device cleared by the FDA?
Smartsuction Solo Device (K062801) received a 510(k) decision of Substantially Equivalent on October 4, 2006, 15 days after the submission was received.
What is the product code of K062801?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.