BTA · Pump, Portable, Aspiration (Manual Or Powered)
General, Plastic Surgery · 21 CFR 878.4780 · Class 2
Overview
| Product Code | BTA |
|---|---|
| Device Name | Pump, Portable, Aspiration (Manual Or Powered) |
| Regulation | 21 CFR 878.4780 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
Identification
A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 155)
Showing 20 most recent of 155 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253107 | Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) | Shenzhen Dongjiang Technology Co., Ltd. | Apr 14, 2026 | SESE |
| K260147 | Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036) | Shenzhen Kingboom Technology Co., Ltd. | Mar 13, 2026 | SESE |
| K251450 | Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009) | Shenzhen Desida Technology Co., Ltd. | Jun 6, 2025 | SESE |
| K244033 | Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610) | Shenzhen Desida Technology Co., Ltd. | May 16, 2025 | SESE |
| K251101 | AIRO Suction Unit (AIRO-01) | Cro, LLC | Apr 26, 2025 | SESE |
| K250697 | Electric Nasal Aspirator (BC026, BC025, BC023) | Shenzhen Kingboom Technology Co., Ltd. | Apr 23, 2025 | SESE |
| K241799 | ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C | Atmos Medizintechnik GmbH & Co. KG | Mar 7, 2025 | SESE |
| K243138 | Geon (S2) Nasal Aspirator | Geon Corporation | Feb 4, 2025 | SESE |
| K241852 | Nasal Aspirator (NS 13) | Avita Corporation | Dec 31, 2024 | SESE |
| K242028 | Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) | Dongguanshi Yiyingmei Technology Co., Ltd. | Nov 19, 2024 | SESE |
| K241202 | Electric nasal aspirator (HTD2601US) | Hetaida Technology Co., Ltd. | Jul 1, 2024 | SESE |
| K233901 | Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009) | Shenzhen Desida Technology Co., Ltd. | Mar 20, 2024 | SESE |
| K232831 | Quiver Aspiration Pump | Anoxia Medical, Inc. | Feb 22, 2024 | SESE |
| K231063 | SOMAVAC® 100 Sustained Vacuum System | Somavac Medical Solutions, Inc. | May 12, 2023 | SESE |
| K221042 | Renova RP Centesis Pump | Gi Supply, Inc. | Apr 19, 2023 | SESE |
| K223373 | Enivo | Aroa Biosurgery , Ltd. | Apr 7, 2023 | SESE |
| K220126 | Geonic Nasal Aspirator, Geonic Nasal Cleaner | Geon Corporation | Feb 2, 2023 | SESE |
| K222547 | Electric nasal aspirator | Shenzhen Xinlianfeng Technology Co.,Ltd | Oct 20, 2022 | SESE |
| K222856 | SOMAVAC 100 Sustained Vacuum System | Somavac Medical Solutions, Inc. | Oct 19, 2022 | SESE |
| K221676 | Exsalta | Drw Medical | Sep 16, 2022 | SESE |
Top Applicants
- Medela AG — 9 clearances
- Thomas Industries — 5 clearances
- Egnell, Inc. — 5 clearances
- Aeros Instruments, Inc. — 5 clearances
- Sscor — 4 clearances
