FDA Product Code
FDA Product Code BTA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4780
510(k) Clearances — 159 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253629 | Momcozy Nasal Aspirator (BN007) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-05-26 | Traditional | PDF ↗ |
| 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. | 2026-05-15 | Traditional | PDF ↗ |
| K260892 | Suction Pump (SU-90) | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2026-05-14 | Traditional | PDF ↗ |
| K260473 | Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B) | Shenzhen Kingboom Technology Co., Ltd. | 2026-05-12 | Traditional | PDF ↗ |
| K253107 | Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) | Shenzhen Dongjiang Technology Co., Ltd. | 2026-04-14 | Traditional | PDF ↗ |
| K260147 | Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036) | Shenzhen Kingboom Technology Co., Ltd. | 2026-03-13 | Traditional | PDF ↗ |
| 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. | 2025-06-06 | Special | PDF ↗ |
| K244033 | Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610) | Shenzhen Desida Technology Co., Ltd. | 2025-05-16 | Traditional | PDF ↗ |
| K251101 | AIRO Suction Unit (AIRO-01) | Cro, LLC | 2025-04-26 | Traditional | PDF ↗ |
| K250697 | Electric Nasal Aspirator (BC026, BC025, BC023) | Shenzhen Kingboom Technology Co., Ltd. | 2025-04-23 | Traditional | PDF ↗ |
| 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 | 2025-03-07 | Traditional | PDF ↗ |
| K243138 | Geon (S2) Nasal Aspirator | Geon Corporation | 2025-02-04 | Special | PDF ↗ |
| K241852 | Nasal Aspirator (NS 13) | Avita Corporation | 2024-12-31 | Traditional | PDF ↗ |
| K242028 | Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) | Dongguanshi Yiyingmei Technology Co., Ltd. | 2024-11-19 | Traditional | PDF ↗ |
| K241202 | Electric nasal aspirator (HTD2601US) | Hetaida Technology Co., Ltd. | 2024-07-01 | Traditional | PDF ↗ |
| K233901 | Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009) | Shenzhen Desida Technology Co., Ltd. | 2024-03-20 | Traditional | PDF ↗ |
| K232831 | Quiver Aspiration Pump | Anoxia Medical, Inc. | 2024-02-22 | Traditional | PDF ↗ |
| K231063 | SOMAVAC® 100 Sustained Vacuum System | Somavac Medical Solutions, Inc. | 2023-05-12 | Special | PDF ↗ |
| K221042 | Renova RP Centesis Pump | Gi Supply, Inc. | 2023-04-19 | Traditional | PDF ↗ |
| K223373 | Enivo | Aroa Biosurgery , Ltd. | 2023-04-07 | Traditional | PDF ↗ |
| K220126 | Geonic Nasal Aspirator, Geonic Nasal Cleaner | Geon Corporation | 2023-02-02 | Traditional | PDF ↗ |
| K222547 | Electric nasal aspirator | Shenzhen Xinlianfeng Technology Co.,Ltd | 2022-10-20 | Traditional | PDF ↗ |
| K222856 | SOMAVAC 100 Sustained Vacuum System | Somavac Medical Solutions, Inc. | 2022-10-19 | Special | PDF ↗ |
| K221676 | Exsalta | Drw Medical | 2022-09-16 | Traditional | PDF ↗ |
| K203135 | Medline Vacu-line Suction Aspirator | Medline Industries, Inc. | 2021-05-04 | Traditional | PDF ↗ |
| K201203 | Cliq Aspirator | Anest Iwata Sparmax Co., Ltd. | 2020-09-03 | Traditional | PDF ↗ |
| K180863 | FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator | Taidoc Technology Corporation | 2018-12-19 | Traditional | PDF ↗ |
| K181667 | Thoraguard System | Centese, Inc. | 2018-11-29 | Traditional | PDF ↗ |
| K180606 | SOMAVAC Device | Somavac Medical Solutions, Inc. | 2018-05-31 | Traditional | PDF ↗ |
| K173389 | Rex Medical Aspiration Pump | Rex Medical, L.P. | 2018-01-30 | Traditional | PDF ↗ |
| K170533 | Model 330 Multifunction Aspirator | ZOLL Medical Corporation | 2017-04-18 | Traditional | PDF ↗ |
| K161002 | Aprima Smartesis Centesis Pump | Cook Incorporated | 2016-09-28 | Traditional | PDF ↗ |
| K153663 | Vario 8/18/ci | Medela AG | 2016-05-18 | Traditional | PDF ↗ |
| K153459 | TACVAC | Athena Gtx | 2016-01-28 | Abbreviated | PDF ↗ |
| K141255 | SIMEX SUBGLOTTIC ASPIRATION SYSTEM | Simex Medizintechnik GmbH | 2014-09-22 | Traditional | PDF ↗ |
| K141553 | MEDELA THOPAZ+ | Medela AG | 2014-08-25 | Special | PDF ↗ |
| K140179 | EASY GO VAC | Precision Medical, Inc. | 2014-04-25 | Special | PDF ↗ |
| K130123 | BASIC AND DOMINANT FLEX SUCTION PUMPS | Medela AG | 2013-10-11 | Traditional | PDF ↗ |
| K130210 | MEDELA THOPAZ | Medela AG | 2013-03-15 | Traditional | PDF ↗ |
| K130131 | EDRAIN CHEST DRAINAGE SYSTEM | Atrium Medical Corp. | 2013-02-28 | Traditional | PDF ↗ |
| K122619 | EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET | Applied Medical | 2012-10-02 | Traditional | PDF ↗ |
| K103042 | ATMOS E 201 THORAX AND ATMOS S 201 THORAX | Atmos, Inc. | 2011-04-15 | Traditional | PDF ↗ |
| K090379 | AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES | Avita Corporation | 2010-05-26 | Traditional | PDF ↗ |
| K093241 | V7 PORTABLE SUCTION UNITS | Hersill, S.L. | 2010-04-27 | Traditional | PDF ↗ |
| K092903 | BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING | Maquet GmbH and Co. KG | 2009-12-01 | Traditional | PDF ↗ |
| K090445 | ATMOS C361/C451 SUCTION PUMP | Atmos, Inc. | 2009-02-27 | Traditional | PDF ↗ |
| K080745 | GENADYNE A4 POWERED SUCTION PUMP | Genadyne Biotechnologies, Inc. | 2008-07-30 | Traditional | PDF ↗ |
| K080212 | MEDELA THOPAZ, MODEL 200 0288 | Medela AG | 2008-07-23 | Traditional | PDF ↗ |
| K081185 | MOBLVAC W.C. | Ohio Medical Corporation | 2008-05-02 | Special | PDF ↗ |
| K071607 | ASA01 HEAVY DUTY SUCTION PUMP | Zhongshan A&J Medical Equipment Co., Ltd. | 2007-06-26 | Traditional | PDF ↗ |
| K062801 | SMARTSUCTION SOLO DEVICE | Haemonetics Corp. | 2006-10-04 | Traditional | PDF ↗ |
| K062610 | CARE-E-VAC 3 | Ohio Medical Corporation | 2006-09-28 | Special | PDF ↗ |
| K061133 | SIMEX SUCTION PUMP, MODELS AC20, AC20K, AC30, DC20, DC30 AND DC30S | Novaspine, LLC | 2006-07-11 | Traditional | PDF ↗ |
| K061205 | MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR | Medela AG | 2006-06-21 | Traditional | PDF ↗ |
| K052650 | PIONEER U601 SERIES ASPIRATOR | Merits Health Products Co., Ltd. | 2005-11-04 | Abbreviated | PDF ↗ |
| K052626 | SMARTSUCTION HARMONY DEVICE | Haemonetics Corp. | 2005-10-05 | Traditional | PDF ↗ |
| K051758 | PENUMBRA ASPIRATION PUMP, MODEL 115V | Penumbra, Inc. | 2005-08-17 | Traditional | PDF ↗ |
| K043544 | MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR | Medela AG | 2005-01-07 | Traditional | PDF ↗ |
| K042943 | NOUVAG AG - VACUSON 40 AND VACUSON 60 | NOUVAG AG | 2004-12-17 | Traditional | PDF ↗ |
| K041405 | ASPIRATION PUMP, MODEL IMD-020 | Industrial & Medical Design, Inc. | 2004-09-02 | Traditional | PDF ↗ |
| K041199 | MEDI-PUMP ASPIRATOR, MODEL 1615 | Thomas Industries | 2004-06-01 | Special | PDF ↗ |
| K041154 | S-SCORT...JR QUICKDRAW, MODEL 2400 | Sscor | 2004-05-18 | Traditional | PDF ↗ |
| K040239 | SUPRAFLOW CONSOLE | Neomedix Corp. | 2004-02-17 | Traditional | PDF ↗ |
| K033179 | MEDELA CLARIO HOME CARE PUMP | Medela AG | 2003-10-15 | Abbreviated | PDF ↗ |
| K021368 | MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057 | Medela AG | 2002-05-15 | Traditional | PDF ↗ |
| K013585 | MEDIPORT 2000 MOBILE | Servox Medizintechnik GmbH | 2002-01-28 | Traditional | PDF ↗ |
| K013116 | DURQ/ QUALIDURA | Ever-Safety Technical Service | 2002-01-18 | Traditional | PDF ↗ |
| K011601 | ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX | Ardo Medical AG | 2001-06-08 | Traditional | PDF ↗ |
| K993668 | LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 | Laerdal Medical A/S | 1999-12-20 | Traditional | PDF ↗ |
| K992026 | SORING GMBH, SONOCA 300 | Soring GmbH Medizintechnik | 1999-09-23 | Traditional | PDF ↗ |
| K984363 | XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM | Xomed, Inc. | 1999-02-26 | Traditional | PDF ↗ |
| K982371 | MEDCO ASPIRATOR IV | Medco Mfg. | 1999-02-12 | Abbreviated | PDF ↗ |
| K983552 | BASIC, MEDIAN, DOMINANT, AND VARIO | Medela, Inc. | 1999-01-07 | Abbreviated | PDF ↗ |
| K981703 | KSEA UNIMAT 45 | Karl Storz Endoscopy | 1998-08-12 | Traditional | PDF ↗ |
| K981602 | DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR | Sunrise Medical Hhg, Inc. | 1998-07-17 | Traditional | PDF ↗ |
| K971749 | EASYGO ASPIRATOR | Precision Medical, Inc. | 1998-04-01 | Traditional | PDF ↗ |
| K980301 | IP-16 | Servizi Medico Estetici Italinai Srl. | 1998-03-24 | Traditional | PDF ↗ |
| K980454 | LYSONIX ASPIRATION PUMP | Lysonix, Inc. | 1998-03-18 | Traditional | PDF ↗ |
| K980392 | PSI-TEC ASPIRATOR | Byron Medical | 1998-03-05 | Traditional | PDF ↗ |
| K973268 | MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM | Microaire Surgical Instruments, Inc. | 1997-11-26 | Traditional | PDF ↗ |
| K971107 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5 | Alexander Mfg. Co. | 1997-06-05 | Traditional | PDF ↗ |
| K963775 | MODEL 8800 ASPIRATOR | Medical Specifics, Inc. | 1997-03-26 | Traditional | PDF ↗ |
| K964997 | S-SCORT (2500) | Sscor | 1997-03-05 | Traditional | PDF ↗ |
| K965059 | CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243) | Thomas Industries | 1997-03-04 | Traditional | PDF ↗ |
| K970186 | GI SUPPLY PARACENTESIS PUMP | Gi Supply | 1997-02-14 | Traditional | PDF ↗ |
| K960492 | SI CONTROLLER MODEL SI 500 | I.C Medical, Inc. | 1996-12-23 | Traditional | PDF ↗ |
| K954264 | ACI SINGLE LUMEN BIOPSY NEEDLE | Advanced Cytometrix, Inc. | 1995-11-29 | Traditional | PDF ↗ |
| K954287 | ACI FINE NEEDLE ASPIRATION BIOPSY KIT | Advanced Cytometrix, Inc. | 1995-11-29 | Traditional | PDF ↗ |
| K954286 | ACI PULSATING VACUUM PUMP SYSTEM | Advanced Cytometrix, Inc. | 1995-11-29 | Traditional | PDF ↗ |
| K952806 | MEDI PUMP ASPIRATOR MODELS 1130 AND 1135 | Thomas Industries | 1995-10-26 | Traditional | PDF ↗ |
| K953132 | UIMAT PUMP | KARL STORZ Endoscopy-America, Inc. | 1995-08-23 | Traditional | PDF ↗ |
| K951729 | MEDI - PUMP | Thomas Industries | 1995-08-21 | Traditional | PDF ↗ |
| K952103 | AEROS ASPIRATOR | Aeros Instruments, Inc. | 1995-07-31 | Traditional | PDF ↗ |
| K952632 | S-SCORT | Sscor | 1995-06-16 | Traditional | PDF ↗ |
| K951326 | BIOPSY DEVICE ACCESSORY | Biopsys Medical, Inc. | 1995-05-15 | Traditional | PDF ↗ |
| K950495 | SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000 | Surgical Dynamics, Inc. | 1995-05-09 | Traditional | PDF ↗ |
| K932031 | AMBU PORTABLE SUCTION UNIT | Ambu, Inc. | 1995-05-05 | Traditional | PDF ↗ |
| K951423 | ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT | Impact Instrumentation, Inc. | 1995-04-18 | Traditional | PDF ↗ |
| K941961 | 605 VACU-MAX | Medical Industries America, Inc. | 1995-03-02 | Traditional | PDF ↗ |
| K944399 | MEDI-PUMP | Thomas Industries | 1995-01-18 | Traditional | PDF ↗ |
Product code BTA · Class II · General, Plastic Surgery. Data: openFDA.