BTA — Pump, Portable, Aspiration (Manual Or Powered) Class II
FDA product code BTA covers "Pump, Portable, Aspiration (Manual Or Powered)", a Class II medical device regulated under 21 CFR 878.4780. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- BTA
- Device Class
- Class II
- Regulation Number
- 878.4780
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253629 | shenzhen root innovation technology co | Momcozy Nasal Aspirator (BN007) | May 26, 2026 |
| K260134 | shenzhen root innovation technology co | Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN | May 15, 2026 |
| K260892 | shenzhen hugemed medical technical development co | Suction Pump (SU-90) | May 14, 2026 |
| K260473 | shenzhen kingboom technology co | Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B) | May 12, 2026 |
| K253107 | shenzhen dongjiang technology co | Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) | April 14, 2026 |
| K260147 | shenzhen kingboom technology co | Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036) | March 13, 2026 |
| K251450 | shenzhen desida technology co | Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator | June 6, 2025 |
| K244033 | shenzhen desida technology co | Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA61 | May 16, 2025 |
| K251101 | cro | AIRO Suction Unit (AIRO-01) | April 26, 2025 |
| K250697 | shenzhen kingboom technology co | Electric Nasal Aspirator (BC026, BC025, BC023) | April 23, 2025 |
| K241799 | atmos medizintechnik gmbh and co. kg | ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose sys | March 7, 2025 |
| K243138 | geon corporation | Geon (S2) Nasal Aspirator | February 4, 2025 |
| K241852 | avita corporation | Nasal Aspirator (NS 13) | December 31, 2024 |
| K242028 | dongguanshi yiyingmei technology co | Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) | November 19, 2024 |
| K241202 | hetaida technology co | Electric nasal aspirator (HTD2601US) | July 1, 2024 |
| K233901 | shenzhen desida technology co | Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009 | March 20, 2024 |
| K232831 | anoxia medical | Quiver Aspiration Pump | February 22, 2024 |
| K231063 | somavac medical solutions | SOMAVAC® 100 Sustained Vacuum System | May 12, 2023 |
| K221042 | gi supply | Renova RP Centesis Pump | April 19, 2023 |
| K223373 | aroa biosurgery | Enivo | April 7, 2023 |