Panels › General, Plastic Surgery › Product code BTA · Class 2
Pump, Portable, Aspiration (Manual Or Powered)
Regulation 878.4780
7510(k)s in 12 months (160 all time)
0recalls in 12 months (21 all time)
16recalls that name a 510(k)
Top companies in BTA
| Company | 510(k)s | Recalls |
|---|---|---|
| Medela AG | 10 | 0 |
| Ohio Medical Corporation | 2 | 5 |
| S S C O R Inc | 0 | 6 |
| Aeros Instruments, Inc. | 5 | 0 |
| Egnell, Inc. | 5 | 0 |
| Precision Medical, Inc. | 3 | 2 |
| Thomas Industries | 5 | 0 |
| Sscor | 4 | 0 |
| Advanced Cytometrix, Inc. | 3 | 0 |
| Haemonetics Corp. | 2 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 7, 2026 | K262822 | Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401) Zhongshan GL Electronics Co. , Ltd., CN | BTA |
| May 26, 2026 | K253629 | Momcozy Nasal Aspirator (BN007) Shenzhen Root Innovation Technology Co., Ltd., CN | BTA |
| May 15, 2026 | K260134 | Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021 Shenzhen Root Innovation Technology Co., Ltd., CN | BTA |
| May 14, 2026 | K260892 | Suction Pump (SU-90) Shenzhen HugeMed Medical Technical Development Co., Ltd., CN | BTA |
| May 12, 2026 | K260473 | Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B) Shenzhen Kingboom Technology Co., Ltd., CN | BTA |
| Apr 14, 2026 | K253107 | Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) Shenzhen Dongjiang Technology Co., Ltd., CN | BTA |
| Mar 13, 2026 | K260147 | Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036) Shenzhen Kingboom Technology Co., Ltd., CN | BTA |
| Jun 6, 2025 | K251450 | Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Shenzhen Desida Technology Co., Ltd., CN | BTA |
| May 16, 2025 | K244033 | Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610) Shenzhen Desida Technology Co., Ltd., CN | BTA |
| Apr 26, 2025 | K251101 | AIRO Suction Unit (AIRO-01) Cro, LLC | BTA |
| Apr 23, 2025 | K250697 | Electric Nasal Aspirator (BC026, BC025, BC023) Shenzhen Kingboom Technology Co., Ltd., CN | BTA |
| Mar 7, 2025 | K241799 | ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with conne Atmos Medizintechnik GmbH & Co. KG, DE | BTA |
| Feb 4, 2025 | K243138 | Geon (S2) Nasal Aspirator Geon Corporation, TW | BTA |
| Dec 31, 2024 | K241852 | Nasal Aspirator (NS 13) Avita Corporation, TW | BTA |
| Nov 19, 2024 | K242028 | Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) Dongguanshi Yiyingmei Technology Co., Ltd., CN | BTA |
| Jul 1, 2024 | K241202 | Electric nasal aspirator (HTD2601US) Hetaida Technology Co., Ltd., CN | BTA |
| Mar 20, 2024 | K233901 | Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009) Shenzhen Desida Technology Co., Ltd., CN | BTA |
| Feb 22, 2024 | K232831 | Quiver Aspiration Pump Anoxia Medical, Inc. | BTA |
| May 12, 2023 | K231063 | SOMAVAC® 100 Sustained Vacuum System Somavac Medical Solutions, Inc. | BTA |
| Apr 19, 2023 | K221042 | Renova RP Centesis Pump Gi Supply, Inc. | BTA |
| Apr 7, 2023 | K223373 | Enivo Aroa Biosurgery , Ltd., NZ | BTA |
| Feb 2, 2023 | K220126 | Geonic Nasal Aspirator, Geonic Nasal Cleaner Geon Corporation, TW | BTA |
| Oct 20, 2022 | K222547 | Electric nasal aspirator Shenzhen Xinlianfeng Technology Co.,Ltd, CN | BTA |
| Oct 19, 2022 | K222856 | SOMAVAC 100 Sustained Vacuum System Somavac Medical Solutions, Inc. | BTA |
| Sep 16, 2022 | K221676 | Exsalta Drw Medical | BTA |
| May 4, 2021 | K203135 | Medline Vacu-line Suction Aspirator Medline Industries, Inc. | BTA |
| Sep 3, 2020 | K201203 | Cliq Aspirator Anest Iwata Sparmax Co., Ltd., TW | BTA |
| Dec 19, 2018 | K180863 | FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator Taidoc Technology Corporation, TW | BTA |
| Nov 29, 2018 | K181667 | Thoraguard System Centese, Inc. | BTA |
| May 31, 2018 | K180606 | SOMAVAC Device Somavac Medical Solutions, Inc. | BTA |
| Jan 30, 2018 | K173389 | Rex Medical Aspiration Pump Rex Medical, L.P. | BTA |
| Apr 18, 2017 | K170533 | Model 330 Multifunction Aspirator ZOLL Medical Corporation | BTA |
| Sep 28, 2016 | K161002 | Aprima Smartesis Centesis Pump Cook Incorporated | BTA |
| May 18, 2016 | K153663 | Vario 8/18/ci Medela AG, CH | BTA |
| Jan 28, 2016 | K153459 | TACVAC Athena Gtx | BTA |
| Sep 22, 2014 | K141255 | SIMEX SUBGLOTTIC ASPIRATION SYSTEM Simex Medizintechnik GmbH | BTA |
| Aug 25, 2014 | K141553 | MEDELA THOPAZ+ Medela AG, CH | BTA |
| Apr 25, 2014 | K140179 | EASY GO VAC Precision Medical, Inc. | BTA |
| Oct 11, 2013 | K130123 | BASIC AND DOMINANT FLEX SUCTION PUMPS Medela AG | BTA |
| Mar 15, 2013 | K130210 | MEDELA THOPAZ Medela AG, CH | BTA |
| Feb 28, 2013 | K130131 | EDRAIN CHEST DRAINAGE SYSTEM Atrium Medical Corp. | BTA |
| Oct 2, 2012 | K122619 | EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET Applied Medical | BTA |
| Apr 15, 2011 | K103042 | ATMOS E 201 THORAX AND ATMOS S 201 THORAX Atmos, Inc. | BTA |
| May 26, 2010 | K090379 | AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES Avita Corporation | BTA |
| Apr 27, 2010 | K093241 | V7 PORTABLE SUCTION UNITS Hersill, S.L., ES | BTA |
| Dec 1, 2009 | K092903 | BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING Maquet GmbH and Co. KG, DE | BTA |
| Feb 27, 2009 | K090445 | ATMOS C361/C451 SUCTION PUMP Atmos, Inc. | BTA |
| Jul 30, 2008 | K080745 | GENADYNE A4 POWERED SUCTION PUMP Genadyne Biotechnologies, Inc. | BTA |
| Jul 23, 2008 | K080212 | MEDELA THOPAZ, MODEL 200 0288 Medela AG, CH | BTA |
| May 2, 2008 | K081185 | MOBLVAC W.C. Ohio Medical Corporation | BTA |
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