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.
Cleared Devices (155)
| 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 |
| K203135 | Medline Vacu-line Suction Aspirator | Medline Industries, Inc. | May 4, 2021 | SESE |
| K201203 | Cliq Aspirator | Anest Iwata Sparmax Co., Ltd. | Sep 3, 2020 | SESE |
| K180863 | FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator | Taidoc Technology Corporation | Dec 19, 2018 | SESE |
| K181667 | Thoraguard System | Centese, Inc. | Nov 29, 2018 | SESE |
| K180606 | SOMAVAC Device | Somavac Medical Solutions, Inc. | May 31, 2018 | SESE |
| K173389 | Rex Medical Aspiration Pump | Rex Medical, L.P. | Jan 30, 2018 | SESE |
| K170533 | Model 330 Multifunction Aspirator | ZOLL Medical Corporation | Apr 18, 2017 | SESE |
| K161002 | Aprima Smartesis Centesis Pump | Cook Incorporated | Sep 28, 2016 | SESE |
| K153663 | Vario 8/18/ci | Medela AG | May 18, 2016 | SESE |
| K153459 | TACVAC | Athena Gtx | Jan 28, 2016 | SESE |
| K141255 | SIMEX SUBGLOTTIC ASPIRATION SYSTEM | Simex Medizintechnik GmbH | Sep 22, 2014 | SESE |
| K141553 | MEDELA THOPAZ+ | Medela AG | Aug 25, 2014 | SESE |
| K140179 | EASY GO VAC | Precision Medical, Inc. | Apr 25, 2014 | SESE |
| K130123 | BASIC AND DOMINANT FLEX SUCTION PUMPS | Medela AG | Oct 11, 2013 | SESE |
| K130210 | MEDELA THOPAZ | Medela AG | Mar 15, 2013 | SESE |
| K130131 | EDRAIN CHEST DRAINAGE SYSTEM | Atrium Medical Corp. | Feb 28, 2013 | SESE |
| K122619 | EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET | Applied Medical | Oct 2, 2012 | SESE |
| K103042 | ATMOS E 201 THORAX AND ATMOS S 201 THORAX | Atmos, Inc. | Apr 15, 2011 | SESE |
| K090379 | AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES | Avita Corporation | May 26, 2010 | SESE |
| K093241 | V7 PORTABLE SUCTION UNITS | Hersill, S.L. | Apr 27, 2010 | SESE |
| K092903 | BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING | Maquet GmbH and Co. KG | Dec 1, 2009 | SESE |
| K090445 | ATMOS C361/C451 SUCTION PUMP | Atmos, Inc. | Feb 27, 2009 | SESE |
| K080745 | GENADYNE A4 POWERED SUCTION PUMP | Genadyne Biotechnologies, Inc. | Jul 30, 2008 | SESE |
| K080212 | MEDELA THOPAZ, MODEL 200 0288 | Medela AG | Jul 23, 2008 | SESE |
| K081185 | MOBLVAC W.C. | Ohio Medical Corporation | May 2, 2008 | SESE |
| K071607 | ASA01 HEAVY DUTY SUCTION PUMP | Zhongshan A&J Medical Equipment Co., Ltd. | Jun 26, 2007 | SESE |
| K062801 | SMARTSUCTION SOLO DEVICE | Haemonetics Corp. | Oct 4, 2006 | SESE |
| K062610 | CARE-E-VAC 3 | Ohio Medical Corporation | Sep 28, 2006 | SESE |
| K061133 | SIMEX SUCTION PUMP, MODELS AC20, AC20K, AC30, DC20, DC30 AND DC30S | Novaspine, LLC | Jul 11, 2006 | SESE |
| K061205 | MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR | Medela AG | Jun 21, 2006 | SESE |
| K052650 | PIONEER U601 SERIES ASPIRATOR | Merits Health Products Co., Ltd. | Nov 4, 2005 | SESE |
| K052626 | SMARTSUCTION HARMONY DEVICE | Haemonetics Corp. | Oct 5, 2005 | SESE |
| K051758 | PENUMBRA ASPIRATION PUMP, MODEL 115V | Penumbra, Inc. | Aug 17, 2005 | SESE |
| K043544 | MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR | Medela AG | Jan 7, 2005 | SESE |
| K042943 | NOUVAG AG - VACUSON 40 AND VACUSON 60 | NOUVAG AG | Dec 17, 2004 | SESE |
| K041405 | ASPIRATION PUMP, MODEL IMD-020 | Industrial & Medical Design, Inc. | Sep 2, 2004 | SESE |
| K041199 | MEDI-PUMP ASPIRATOR, MODEL 1615 | Thomas Industries | Jun 1, 2004 | SESE |
| K041154 | S-SCORT...JR QUICKDRAW, MODEL 2400 | Sscor | May 18, 2004 | SESE |
| K040239 | SUPRAFLOW CONSOLE | Neomedix Corp. | Feb 17, 2004 | SESE |
| K033179 | MEDELA CLARIO HOME CARE PUMP | Medela AG | Oct 15, 2003 | SESE |
| K021368 | MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057 | Medela AG | May 15, 2002 | SESE |
| K013585 | MEDIPORT 2000 MOBILE | Servox Medizintechnik GmbH | Jan 28, 2002 | SESE |
| K013116 | DURQ/ QUALIDURA | Ever-Safety Technical Service | Jan 18, 2002 | SESE |
| K011601 | ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX | Ardo Medical AG | Jun 8, 2001 | SESE |
| K993668 | LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 | Laerdal Medical A/S | Dec 20, 1999 | SESE |
| K992026 | SORING GMBH, SONOCA 300 | Soring GmbH Medizintechnik | Sep 23, 1999 | SESE |
| K984363 | XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM | Xomed, Inc. | Feb 26, 1999 | SESE |
| K982371 | MEDCO ASPIRATOR IV | Medco Mfg. | Feb 12, 1999 | SESE |
| K983552 | BASIC, MEDIAN, DOMINANT, AND VARIO | Medela, Inc. | Jan 7, 1999 | SESE |
| K981703 | KSEA UNIMAT 45 | Karl Storz Endoscopy | Aug 12, 1998 | SESE |
| K981602 | DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR | Sunrise Medical Hhg, Inc. | Jul 17, 1998 | SESE |
| K971749 | EASYGO ASPIRATOR | Precision Medical, Inc. | Apr 1, 1998 | SESE |
| K980301 | IP-16 | Servizi Medico Estetici Italinai Srl. | Mar 24, 1998 | SESE |
| K980454 | LYSONIX ASPIRATION PUMP | Lysonix, Inc. | Mar 18, 1998 | SESE |
| K980392 | PSI-TEC ASPIRATOR | Byron Medical | Mar 5, 1998 | SESE |
| K973268 | MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM | Microaire Surgical Instruments, Inc. | Nov 26, 1997 | SESE |
| K971107 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5 | Alexander Mfg. Co. | Jun 5, 1997 | SESE |
| K963775 | MODEL 8800 ASPIRATOR | Medical Specifics, Inc. | Mar 26, 1997 | SESE |
| K964997 | S-SCORT (2500) | Sscor | Mar 5, 1997 | SESE |
| K965059 | CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243) | Thomas Industries | Mar 4, 1997 | SESE |
| K970186 | GI SUPPLY PARACENTESIS PUMP | Gi Supply | Feb 14, 1997 | SESE |
| K960492 | SI CONTROLLER MODEL SI 500 | I.C Medical, Inc. | Dec 23, 1996 | SESE |
| K954287 | ACI FINE NEEDLE ASPIRATION BIOPSY KIT | Advanced Cytometrix, Inc. | Nov 29, 1995 | SESE |
| K954286 | ACI PULSATING VACUUM PUMP SYSTEM | Advanced Cytometrix, Inc. | Nov 29, 1995 | SESE |
| K954264 | ACI SINGLE LUMEN BIOPSY NEEDLE | Advanced Cytometrix, Inc. | Nov 29, 1995 | SESE |
| K952806 | MEDI PUMP ASPIRATOR MODELS 1130 AND 1135 | Thomas Industries | Oct 26, 1995 | SESE |
| K953132 | UIMAT PUMP | KARL STORZ Endoscopy-America, Inc. | Aug 23, 1995 | SESE |
| K951729 | MEDI - PUMP | Thomas Industries | Aug 21, 1995 | SESE |
| K952103 | AEROS ASPIRATOR | Aeros Instruments, Inc. | Jul 31, 1995 | SESE |
| K952632 | S-SCORT | Sscor | Jun 16, 1995 | SESE |
| K951326 | BIOPSY DEVICE ACCESSORY | Biopsys Medical, Inc. | May 15, 1995 | SESE |
| K950495 | SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000 | Surgical Dynamics, Inc. | May 9, 1995 | SESE |
| K932031 | AMBU PORTABLE SUCTION UNIT | Ambu, Inc. | May 5, 1995 | SESE |
| K951423 | ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT | Impact Instrumentation, Inc. | Apr 18, 1995 | SESE |
| K941961 | 605 VACU-MAX | Medical Industries America, Inc. | Mar 2, 1995 | SESE |
| K944399 | MEDI-PUMP | Thomas Industries | Jan 18, 1995 | SESE |
| K941096 | ELECTRIC VACUM PUMP | Impact Instrumentation, Inc. | Jan 5, 1995 | SESE |
| K945929 | S-SCORT(R)DUET MODEL 2014 PORTABLE SUCTION PUMP | Sscor | Dec 22, 1994 | SESE |
| K944818 | COOK ASPIRATION/IRRIGATION UNIT | Cook Urological, Inc. | Nov 8, 1994 | SESE |
| K944116 | FREEDOM ASPIRATOR, MODEL 6000 | Stackhouse, Inc. | Sep 7, 1994 | SESE |
| K933757 | HAND-HELD IRRIGATION PUMP | Ximed Medical Systems | Aug 26, 1994 | SESE |
| K942033 | R&D BATTERIES, PART NOS. 5243, 5104, AND 5481 | R & D Batteries, Inc. | Jun 28, 1994 | SESE |
| K933902 | MOBLVAC III | Aeros Instruments, Inc. | May 20, 1994 | SESE |
| K941578 | STATVAC PORTABLE SUCTION UNIT | Laerdal California, Inc. | May 18, 1994 | SESE |
| K940934 | LIFE VAC | Life Support Products, Inc. | May 3, 1994 | SESE |
| K934976 | INSTAVAC II | Aeros Instruments, Inc. | May 2, 1994 | SESE |
| K931348 | BATTERY PACK #1005NC | Portable Power Systems, Inc. | Feb 17, 1994 | SESE |
| K932051 | TOTE-L-VAC | Aeros Instruments, Inc. | Nov 12, 1993 | SESE |
| K932494 | PM PUMP ASPIRATOR | Precision Medical, Inc. | Oct 7, 1993 | SESE |
| K926566 | CARE-E-VAC | Aeros Instruments, Inc. | Jul 9, 1993 | SESK |
| K930549 | LAERDAL ALTERNATIVE POWER, 5-6 A,5-6 B,2000 | Rustronics, Inc. | Jun 18, 1993 | SESE |
| K920628 | QUINEVAC EVACUATOR/ASPIRATOR | Recto Molded Products, Inc. | Mar 23, 1993 | SESE |
| K922176 | INTELIJET SUCTION SUPPLY | Smith & Nephew Dyonics, Inc. | Nov 18, 1992 | SESE |
| K921107 | AUTOVAC | Life Support Products, Inc. | Sep 17, 1992 | SESE |
| K921611 | MADAVAC 190 | Mada Medical Products, Inc. | Sep 9, 1992 | SESE |
| K910271 | VACPAC PORTABLE ASPIRATION SYSTEM | Jedmed Instrument Co. | Mar 20, 1991 | SESE |
| K891129 | SERIES 3 GENERAL SUCTION SYSTEM | Ultravac, Inc. | Sep 25, 1989 | SESE |
| K883582 | VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM | Surgidyne, Inc. | Oct 3, 1988 | SESE |
| K874157 | LASE EVACUATOR/ASPIRATOR | Lase, Inc. | Mar 21, 1988 | SESE |
| K873940 | CREAT BRAND O-RISE GENERAL ASPIRATOR | Aesthetech Corp. | Nov 25, 1987 | SESE |
| K873462 | VAN DELLEN ASPIRATOR | Van Dellen, Ltd. | Sep 25, 1987 | SESE |
| K871570 | APEX ALPHA VACUUM PUMP | Apex Medical, Inc. | Aug 18, 1987 | SESE |
| K870094 | BUNN MODEL 530 ASPIRATOR | The John Bunn Co. | Mar 6, 1987 | SESE |
| K862875 | E-VAC(TM) | Laerdal California, Inc. | Nov 3, 1986 | SESE |
| K862569 | HEAVY DUTY (HD) SUCTION UNITS (W/CANNULAS) | Jedmed Instrument Co. | Aug 14, 1986 | SN |
| K862751 | USA ASPIRATOR | U. S. A. Medical Corp. | Aug 4, 1986 | SN |
| K860030 | SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID | Surgidyne, Inc. | Feb 12, 1986 | SESE |
| K854844 | LS1000 SURGICAL ASPIRATOR II | Engineering, Inc. | Feb 12, 1986 | SN |
| K851560 | PORTASPIR II | Roseburg SA | Dec 13, 1985 | SESE |
| K853917 | EGNELL COMPACT SUCTION PUMP | Egnell, Inc. | Nov 25, 1985 | SN |
| K853909 | EGNELL UNIVERSAL SUCTION PUMP | Egnell, Inc. | Nov 25, 1985 | SN |
| K850946 | SURGICAL ASPIRATOR | Medicalex | Sep 16, 1985 | SN |
| K852646 | THERMATIC SUCTION PUMP | H.C.H. Products, Inc. | Aug 15, 1985 | SESE |
| K844200 | K.M. PRODUCTS ASPIRATOR | Km Products | Jan 25, 1985 | SESE |
| K843644 | STORZ ASPIRATION MACHINE SAM 5000 | Storz Instrument Co. | Nov 16, 1984 | SESE |
| K843693 | JACOBS HIGH VACUUM SUCTION UNIT 05-2570 | J. Sklar Mfg. Co., Inc. | Oct 31, 1984 | SESE |
| K843750 | APPARATUS, SUCTION, WARD USE, PORTAB- | H.C.H. Products, Inc. | Oct 11, 1984 | SESE |
| K842204 | DMI ASPIRATOR 500 | Dean Medical Instruments, Inc. | Aug 10, 1984 | SESE |
| K841399 | BRONCHOSCOPE SUCTION UNIT | Keymed, Inc. | Jul 18, 1984 | SESE |
| K841903 | FRASER HARLAKE EMERG. CARE SUCTION SYS | Fraser Harlake, Inc. | Jun 14, 1984 | SESE |
| K840803 | GRAMS ASPIRATOR S-300 | Grams Medical, Inc. | May 21, 1984 | SESE |
| K840110 | LAERDAL SUCTION UNIT | Laerdal Medical Corp. | Mar 12, 1984 | SESE |
| K833785 | EMERGENCY ASPIRATOR | Vitalograph , Ltd. | Dec 22, 1983 | SESE |
| K832274 | ASPIRATOR | Wells Johnson Co. | Oct 20, 1983 | SESE |
| K832100 | PSI SURGICAL ASPIRATOR | Advanced Biosearch Assn. | Oct 4, 1983 | SESE |
| K831085 | SYNEVAC VACUUM SOURCE UNIT | Synemed, Inc. | Jun 8, 1983 | SESE |
| K831007 | CONNECTING TUBES | Medovations, Inc. | May 18, 1983 | SESE |
| K821321 | SNYDER DEBRIBEMENT SYSTEM LDP-1 | Snyder Laboratories, Inc. | Aug 6, 1982 | SESE |
| K820739 | KEYMED KEY VAC SUCTION PUMP | Keymed, Inc. | May 21, 1982 | SESE |
| K820338 | IMPACT, MODELS 306/307 | Impact Instrumentation, Inc. | Mar 2, 1982 | SESE |
| K813312 | UNIVERSAL SUCTION PUMP TYPE EUS | Egnell, Inc. | Dec 31, 1981 | SESE |
| K813095 | GASTRIC JUICES SUCTION PUMP | Egnell, Inc. | Dec 9, 1981 | SESE |
| K812020 | EGNELL COMPACT, TYPE EHV | Egnell, Inc. | Oct 20, 1981 | SESE |
| K810490 | GOMCO SUCTION PUMP CABINET CHANGE | Allied Healthcare Products, Inc. | Mar 13, 1981 | SESE |
| K791349 | SYSTEC 280 INTEGRATED SUCTION SYSTEM | Stryker Corp. | Sep 7, 1979 | SESE |
Top Applicants
- Medela AG — 9 clearances
- Thomas Industries — 5 clearances
- Egnell, Inc. — 5 clearances
- Aeros Instruments, Inc. — 5 clearances
- Sscor — 4 clearances
