BTA
- Product code
- BTA
- Device name
- Pump, Portable, Aspiration (Manual Or Powered)
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4780
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 17
- Summaries archived here
- 15 (direct download)
- 510(k) clearances (all years, FDA)
- 159 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (17)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253629 | 2026-05-26 | Shenzhen Root Innovation Technology Co… | Momcozy Nasal Aspirator (BN007) | |
| K260134 | 2026-05-15 | Shenzhen Root Innovation Technology Co… | Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006… | |
| K260892 | 2026-05-14 | Shenzhen HugeMed Medical Technical Dev… | Suction Pump (SU-90) | |
| K260473 | 2026-05-12 | Shenzhen Kingboom Technology Co., Ltd. | Electric nasal aspirator (BC027, BC030, BC033, BC035… | FDA |
| K253107 | 2026-04-14 | Shenzhen Dongjiang Technology Co., Ltd… | Electric Nasal Aspirator (DT10 and DT50, DX80, DX85,… | |
| K260147 | 2026-03-13 | Shenzhen Kingboom Technology Co., Ltd. | Electric nasal aspirator (BC026, BC025, BC023, BC028… | |
| K251450 | 2025-06-06 | Shenzhen Desida Technology Co., Ltd. | Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (… | — |
| K244033 | 2025-05-16 | Shenzhen Desida Technology Co., Ltd. | Electric Nasal Aspirator (NASA601,NASA602,NASA603,NA… | |
| K251101 | 2025-04-26 | Cro, LLC | AIRO Suction Unit (AIRO-01) | |
| K250697 | 2025-04-23 | Shenzhen Kingboom Technology Co., Ltd. | Electric Nasal Aspirator (BC026, BC025, BC023) | |
| K241799 | 2025-03-07 | Atmos Medizintechnik GmbH & Co. KG | ATMOS C 051 Thorax (317.0200.0); Secretion canister … | |
| K243138 | 2025-02-04 | Geon Corporation | Geon (S2) Nasal Aspirator | |
| K241852 | 2024-12-31 | Avita Corporation | Nasal Aspirator (NS 13) | |
| K242028 | 2024-11-19 | Dongguanshi Yiyingmei Technology Co., … | Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-… | |
| K241202 | 2024-07-01 | Hetaida Technology Co., Ltd. | Electric nasal aspirator (HTD2601US) | |
| K233901 | 2024-03-20 | Shenzhen Desida Technology Co., Ltd. | Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA00… | |
| K232831 | 2024-02-22 | Anoxia Medical, Inc. | Quiver Aspiration Pump |
Official FDA classification page: BTA
Classification and pathway per current FDA publications. Data from openFDA (CC0).