BTA
- 产品代码
- BTA
- 器械名称
- Pump, Portable, Aspiration (Manual Or Powered)
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 878.4780
- FDA 专业组
- General, Plastic Surgery
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 159 件
该代码近三年的 510(k)（17 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| 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 |
FDA 官方分类页： BTA
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。