Pump, Portable, Aspiration (Manual Or Powered)

FDA product code BTA · Class II (moderate risk) · 21 CFR 878.4780 · General, Plastic Surgery

159510(k) clearances
0PMA approvals
13recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K253629Momcozy Nasal Aspirator (BN007)BTA · Traditional Shenzhen Root Innovation Technology Co., Ltd.05/26/2026SE
K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A…BTA · Traditional Shenzhen Root Innovation Technology Co., Ltd.05/15/2026SE
K260892Suction Pump (SU-90)BTA · Traditional Shenzhen HugeMed Medical Technical Development…05/14/2026SE
K260473Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)BTA · Traditional Shenzhen Kingboom Technology Co., Ltd.05/12/2026SE
K253107Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)BTA · Traditional Shenzhen Dongjiang Technology Co., Ltd.04/14/2026SE
K260147Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)BTA · Traditional Shenzhen Kingboom Technology Co., Ltd.03/13/2026SE
K251450Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator…BTA · Special Shenzhen Desida Technology Co., Ltd.06/06/2025SE
K244033Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)BTA · Traditional Shenzhen Desida Technology Co., Ltd.05/16/2025SE
K251101AIRO Suction Unit (AIRO-01)BTA · Traditional Cro, LLC04/26/2025SE
K250697Electric Nasal Aspirator (BC026, BC025, BC023)BTA · Traditional Shenzhen Kingboom Technology Co., Ltd.04/23/2025SE
K241799ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system…BTA · Traditional Atmos Medizintechnik GmbH & Co. KG03/07/2025SE
K243138Geon (S2) Nasal AspiratorBTA · Special Geon Corporation02/04/2025SE
K241852Nasal Aspirator (NS 13)BTA · Traditional Avita Corporation12/31/2024SE
K242028Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)BTA · Traditional Dongguanshi Yiyingmei Technology Co., Ltd.11/19/2024SE
K241202Electric nasal aspirator (HTD2601US)BTA · Traditional Hetaida Technology Co., Ltd.07/01/2024SE
K233901Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009)BTA · Traditional Shenzhen Desida Technology Co., Ltd.03/20/2024SE
K232831Quiver Aspiration PumpBTA · Traditional Anoxia Medical, Inc.02/22/2024SE
K231063SOMAVAC® 100 Sustained Vacuum SystemBTA · Special Somavac Medical Solutions, Inc.05/12/2023SE
K221042Renova RP Centesis PumpBTA · Traditional Gi Supply, Inc.04/19/2023SE
K223373Enivo™BTA · Traditional Aroa Biosurgery , Ltd.04/07/2023SE
K220126Geonic Nasal Aspirator, Geonic Nasal CleanerBTA · Traditional Geon Corporation02/02/2023SE
K222547Electric nasal aspiratorBTA · Traditional Shenzhen Xinlianfeng Technology Co.,Ltd10/20/2022SE
K222856SOMAVAC 100 Sustained Vacuum SystemBTA · Special Somavac Medical Solutions, Inc.10/19/2022SE
K221676ExsaltaBTA · Traditional Drw Medical09/16/2022SE
K203135Medline Vacu-line Suction AspiratorBTA · Traditional Medline Industries, Inc.05/04/2021SE
K201203Cliq AspiratorBTA · Traditional Anest Iwata Sparmax Co., Ltd.09/03/2020SE
K180863FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal AspiratorBTA · Traditional Taidoc Technology Corporation12/19/2018SE
K181667Thoraguard SystemBTA · Traditional Centese, Inc.11/29/2018SE
K180606SOMAVAC DeviceBTA · Traditional Somavac Medical Solutions, Inc.05/31/2018SE
K173389Rex Medical Aspiration PumpBTA · Traditional Rex Medical, L.P.01/30/2018SE
K170533Model 330 Multifunction AspiratorBTA · Traditional ZOLL Medical Corporation04/18/2017SE
K161002Aprima Smartesis Centesis PumpBTA · Traditional Cook Incorporated09/28/2016SE
K153663Vario 8/18/ciBTA · Traditional Medela AG05/18/2016SE
K153459TacvacBTA · Abbreviated Athena Gtx01/28/2016SE
K141255Simex Subglottic Aspiration SystemBTA · Traditional Simex Medizintechnik GmbH09/22/2014SE
K141553Medela Thopaz+BTA · Special Medela AG08/25/2014SE
K140179Easy Go VacBTA · Special Precision Medical, Inc.04/25/2014SE
K130123Basic and Dominant Flex Suction PumpsBTA · Traditional Medela AG10/11/2013SE
K130210Medela ThopazBTA · Traditional Medela AG03/15/2013SE
K130131Edrain Chest Drainage SystemBTA · Traditional Atrium Medical Corp.02/28/2013SE
K122619Epix Irrigation Pump, Epix Suction Irrigation Tubing SetBTA · Traditional Applied Medical10/02/2012SE
K103042Atmos E 201 Thorax and Atmos S 201 ThoraxBTA · Traditional Atmos, Inc.04/15/2011SE
K090379Avita Nasal Aspirator, Model, NS1 SeriesBTA · Traditional Avita Corporation05/26/2010SE
K093241V7 Portable Suction UnitsBTA · Traditional Hersill, S.L.04/27/2010SE
K092903Bora Up 2080, Bora Up 2080 Op and Bora Up 2080 MountingBTA · Traditional Maquet GmbH and Co. KG12/01/2009SE
K090445Atmos C361/C451 Suction PumpBTA · Traditional Atmos, Inc.02/27/2009SE
K080745Genadyne A4 Powered Suction PumpBTA · Traditional Genadyne Biotechnologies, Inc.07/30/2008SE
K080212Medela Thopaz, Model 200 0288BTA · Traditional Medela AG07/23/2008SE
K081185Moblvac W.C.BTA · Special Ohio Medical Corporation05/02/2008SE
K071607ASA01 Heavy Duty Suction PumpBTA · Traditional Zhongshan A&J Medical Equipment Co., Ltd.06/26/2007SE
K062801Smartsuction Solo DeviceBTA · Traditional Haemonetics Corp.10/04/2006SE
K062610Care-E-Vac 3BTA · Special Ohio Medical Corporation09/28/2006SE
K061133Simex Suction Pump, Models AC20, AC20K, AC30, DC20, DC30 and DC30SBTA · Traditional Novaspine, LLC07/11/2006SE
K061205Medela Vario 8/18/CI Secretion & Surgical AspiratorBTA · Traditional Medela AG06/21/2006SE
K052650Pioneer U601 Series AspiratorBTA · Abbreviated Merits Health Products Co., Ltd.11/04/2005SE
K052626Smartsuction Harmony DeviceBTA · Traditional Haemonetics Corp.10/05/2005SE
K051758Penumbra Aspiration Pump, Model 115VBTA · Traditional Penumbra, Inc.08/17/2005SE
K043544Medela Dominant 35 C/I Secretion and Surgical AspiratorBTA · Traditional Medela AG01/07/2005SE
K042943Nouvag AG - Vacuson 40 and Vacuson 60BTA · Traditional Nouvag AG12/17/2004SE
K041405Aspiration Pump, Model IMD-020BTA · Traditional Industrial & Medical Design, Inc.09/02/2004SE
K041199Medi-Pump Aspirator, Model 1615BTA · Special Thomas Industries06/01/2004SE
K041154S-Scort...Jr Quickdraw, Model 2400BTA · Traditional Sscor05/18/2004SE
K040239Supraflow ConsoleBTA · Traditional Neomedix Corp.02/17/2004SE
K033179Medela Clario Home Care PumpBTA · Abbreviated Medela AG10/15/2003SE
K021368Medela Basic 30 and Dominant 50 Suction Pumps, Models 037, 057BTA · Traditional Medela AG05/15/2002SE
K013585Mediport 2000 MobileBTA · Traditional Servox Medizintechnik GmbH01/28/2002SE
K013116Durq/ QualiduraBTA · Traditional Ever-Safety Technical Service01/18/2002SE
K011601Ardo Suction Pump Master, Model 30.00.XX; Ardo Suction Pump Senator, Model 31.00.XXBTA · Traditional Ardo Medical AG06/08/2001SE
K993668Laerdal Suction UNIT,(4000) Model 78 00 20BTA · Traditional Laerdal Medical A/S12/20/1999SE
K992026Soring GmbH, Sonoca 300BTA · Traditional Soring GmbH Medizintechnik09/23/1999SE
K984363XPS Tissue Aspiration System, XPS Straightshot or Model 2000 Microdebrider SystemBTA · Traditional Xomed, Inc.02/26/1999SE
K982371Medco Aspirator IVBTA · Abbreviated Medco Mfg.02/12/1999SE
K983552Basic, Median, Dominant, and VarioBTA · Abbreviated Medela, Inc.01/07/1999SE
K981703Ksea Unimat 45BTA · Traditional Karl Storz Endoscopy08/12/1998SE
K981602Devilbiss Model 6305D Heavy Duty Ac AspiratorBTA · Traditional Sunrise Medical Hhg, Inc.07/17/1998SE
K971749Easygo AspiratorBTA · Traditional Precision Medical, Inc.04/01/1998SE
K980301IP-16BTA · Traditional Servizi Medico Estetici Italinai Srl.03/24/1998SE
K980454Lysonix Aspiration PumpBTA · Traditional Lysonix, Inc.03/18/1998SE
K980392Psi-Tec AspiratorBTA · Traditional Byron Medical03/05/1998SE
K973268Microaire Power Aspiration Device Pad SystemBTA · Traditional Microaire Surgical Instruments, Inc.11/26/1997SE
K971107Alexander Manufacturing Co. Rechargeable Battery Part Number STR5BTA · Traditional Alexander Mfg. Co.06/05/1997SE
K963775Model 8800 AspiratorBTA · Traditional Medical Specifics, Inc.03/26/1997SE
K964997S-Scort (2500)BTA · Traditional Sscor03/05/1997SE
K965059Cpi, MAXI-VAC(6480),THOMAS Industries, MEDI-PUMP(1240/1242/1243)BTA · Traditional Thomas Industries03/04/1997SE
K970186Gi Supply Paracentesis PumpBTA · Traditional Gi Supply02/14/1997SE
K960492Si Controller Model Si 500BTA · Traditional I.C Medical, Inc.12/23/1996SE
K954287Aci Fine Needle Aspiration Biopsy KitBTA · Traditional Advanced Cytometrix, Inc.11/29/1995SE
K954286Aci Pulsating Vacuum Pump SystemBTA · Traditional Advanced Cytometrix, Inc.11/29/1995SE
K954264Aci Single Lumen Biopsy NeedleBTA · Traditional Advanced Cytometrix, Inc.11/29/1995SE
K952806Medi Pump Aspirator Models 1130 and 1135BTA · Traditional Thomas Industries10/26/1995SE
K953132Uimat PumpBTA · Traditional KARL STORZ Endoscopy-America, Inc.08/23/1995SE
K951729Medi - PumpBTA · Traditional Thomas Industries08/21/1995SE
K952103Aeros AspiratorBTA · Traditional Aeros Instruments, Inc.07/31/1995SE
K952632S-ScortBTA · Traditional Sscor06/16/1995SE
K951326Biopsy Device AccessoryBTA · Traditional Biopsys Medical, Inc.05/15/1995SE
K950495Sugical Dynamics Endoscopy Irrigation Pump, Catalog #3-4000BTA · Traditional Surgical Dynamics, Inc.05/09/1995SE
K932031Ambu Portable Suction UnitBTA · Traditional Ambu, Inc.05/05/1995SE
K951423Aspirator, Continuous & Programmable IntermittentBTA · Traditional Impact Instrumentation, Inc.04/18/1995SE
K941961605 Vacu-MaxBTA · Traditional Medical Industries America, Inc.03/02/1995SE
K944399Medi-PumpBTA · Traditional Thomas Industries01/18/1995SE
K941096Electric Vacum PumpBTA · Traditional Impact Instrumentation, Inc.01/05/1995SE
K945929S-Scort(R)Duet Model 2014 Portable Suction PumpBTA · Traditional Sscor12/22/1994SE
K944818Cook Aspiration/Irrigation UnitBTA · Traditional Cook Urological, Inc.11/08/1994SE
K944116Freedom Aspirator, Model 6000BTA · Traditional Stackhouse, Inc.09/07/1994SE
K933757Hand-Held Irrigation PumpBTA · Traditional Ximed Medical Systems08/26/1994SE
K942033R&D Batteries, Part Nos. 5243, 5104, and 5481BTA · Traditional R & D Batteries, Inc.06/28/1994SE
K933902Moblvac IIIBTA · Traditional Aeros Instruments, Inc.05/20/1994SE
K941578Statvac Portable Suction UnitBTA · Traditional Laerdal California, Inc.05/18/1994SE
K940934Life VacBTA · Traditional Life Support Products, Inc.05/03/1994SE
K934976Instavac IIBTA · Traditional Aeros Instruments, Inc.05/02/1994SE
K931348Battery Pack #1005NCBTA · Traditional Portable Power Systems, Inc.02/17/1994SE
K932051Tote-L-VacBTA · Traditional Aeros Instruments, Inc.11/12/1993SE
K932494PM Pump AspiratorBTA · Traditional Precision Medical, Inc.10/07/1993SE
K926566Care-E-VacBTA · Traditional Aeros Instruments, Inc.07/09/1993SESK
K930549Laerdal Alternative Power, 5-6 A,5-6 B,2000BTA · Traditional Rustronics, Inc.06/18/1993SE
K920628Quinevac Evacuator/AspiratorBTA · Traditional Recto Molded Products, Inc.03/23/1993SE
K922176Intelijet Suction SupplyBTA · Traditional Smith & Nephew Dyonics, Inc.11/18/1992SE
K921107AutovacBTA · Traditional Life Support Products, Inc.09/17/1992SE
K921611Madavac 190BTA · Traditional Mada Medical Products, Inc.09/09/1992SE
K910271Vacpac Portable Aspiration SystemBTA · Traditional Jedmed Instrument Co.03/20/1991SE
K891129Series 3 General Suction SystemBTA · Traditional Ultravac, Inc.09/25/1989SE
K883582Varidyne Model 250 Suction Drainage SystemBTA · Traditional Surgidyne, Inc.10/03/1988SE
K874157Lase Evacuator/AspiratorBTA · Traditional Lase, Inc.03/21/1988SE
K873940Creat Brand O-Rise General AspiratorBTA · Traditional Aesthetech Corp.11/25/1987SE
K873462Van Dellen AspiratorBTA · Traditional Van Dellen, Ltd.09/25/1987SE
K871570Apex Alpha Vacuum PumpBTA · Traditional Apex Medical, Inc.08/18/1987SE
K870094Bunn Model 530 AspiratorBTA · Traditional The John Bunn Co.03/06/1987SE
K862875E-Vac(Tm)BTA · Traditional Laerdal California, Inc.11/03/1986SE
K862569Heavy Duty (HD) Suction Units (W/Cannulas)BTA · Traditional Jedmed Instrument Co.08/14/1986SN
K862751USA AspiratorBTA · Traditional U. S. A. Medical Corp.08/04/1986SN
K860030Surgidyne Varidyne, Model 140-2I & Model 140-2IDBTA · Traditional Surgidyne, Inc.02/12/1986SE
K854844LS1000 Surgical Aspirator IIBTA · Traditional Engineering, Inc.02/12/1986SN
K851560Portaspir IIBTA · Traditional Roseburg SA12/13/1985SE
K853917Egnell Compact Suction PumpBTA · Traditional Egnell, Inc.11/25/1985SN
K853909Egnell Universal Suction PumpBTA · Traditional Egnell, Inc.11/25/1985SN
K850946Surgical AspiratorBTA · Traditional Medicalex09/16/1985SN
K852646Thermatic Suction PumpBTA · Traditional H.C.H. Products, Inc.08/15/1985SE
K844200K.M. Products AspiratorBTA · Traditional Km Products01/25/1985SE
K843644Storz Aspiration Machine Sam 5000BTA · Traditional Storz Instrument Co.11/16/1984SE
K843693Jacobs High Vacuum Suction Unit 05-2570BTA · Traditional J. Sklar Mfg. Co., Inc.10/31/1984SE
K843750Apparatus, Suction, Ward Use, Portab-BTA · Traditional H.C.H. Products, Inc.10/11/1984SE
K842204Dmi Aspirator 500BTA · Traditional Dean Medical Instruments, Inc.08/10/1984SE
K841399Bronchoscope Suction UnitBTA · Traditional Keymed, Inc.07/18/1984SE
K841903Fraser Harlake Emerg. Care Suction SysBTA · Traditional Fraser Harlake, Inc.06/14/1984SE
K840803Grams Aspirator S-300BTA · Traditional Grams Medical, Inc.05/21/1984SE
K840110Laerdal Suction UnitBTA · Traditional Laerdal Medical Corp.03/12/1984SE
K833785Emergency AspiratorBTA · Traditional Vitalograph , Ltd.12/22/1983SE
K832274AspiratorBTA · Traditional Wells Johnson Co.10/20/1983SE
K832100Psi Surgical AspiratorBTA · Traditional Advanced Biosearch Assn.10/04/1983SE
K831085Synevac Vacuum Source UnitBTA · Traditional Synemed, Inc.06/08/1983SE
K831007Connecting TubesBTA · Traditional Medovations, Inc.05/18/1983SE
K821321Snyder Debribement System LDP-1BTA · Traditional Snyder Laboratories, Inc.08/06/1982SE
K820739Keymed Key Vac Suction PumpBTA · Traditional Keymed, Inc.05/21/1982SE
K820338Impact, Models 306/307BTA · Traditional Impact Instrumentation, Inc.03/02/1982SE
K813312Universal Suction Pump Type EusBTA · Traditional Egnell, Inc.12/31/1981SE
K813095Gastric Juices Suction PumpBTA · Traditional Egnell, Inc.12/09/1981SE
K812020Egnell Compact, Type EhvBTA · Traditional Egnell, Inc.10/20/1981SE
K810490Gomco Suction Pump Cabinet ChangeBTA · Traditional Allied Healthcare Products, Inc.03/13/1981SE
K791349Systec 280 Integrated Suction SystemBTA · Traditional Stryker Corp.09/07/1979SE

Recalls

RecallProductFirmInitiated
Z-2619-2023 Class IIMINISCAV (tm) Vacuum PumpInadequate documentation of acceptance activity R A Medical Services08/23/2023Open, Classified
Z-0482-2022 Class IIInstavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and…Increase in premature device failures Ohio Medical Corporation11/16/2021Open, Classified
Z-1502-2021 Class IIStryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)07612367053921 - Product…Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be… Medela AG Medical Technology12/02/2020Terminated
Z-2995-2018 Class IIPortable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style…The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact with the pump… Ohio Medical Corporation08/14/2018Terminated
Z-1323-2016 Class IIMicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannulaComplaints that the cannula bent/broke during surgery. MicroAire Surgical Instruments, LLC02/08/2016Terminated
Z-0833-2011 Care E Vac 3 Portable Suction; Battery/AC Portable Aspirator; Ohio Medical Corporation…The D-14 diode on the circuit board may fail, resulting in a damaged, overheated circuit board. Also a screw… Ohio Medical Corporation11/08/2010Terminated
Z-1778-2010 NPWT Small Mobile Bag No Logo; an adjunct to the MoblVac Portable Wound Care Pump; Ohio…Ohio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing… Ohio Medical Corporation05/10/2010Terminated
Z-1777-2010 MoblVac Portable Wound Care Pump; an AC/DC powered portable aspirator that provides…Ohio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing… Ohio Medical Corporation05/10/2010Terminated
Z-0162-2009 GlobTek, Inc. Power Supply for Medical Use Part No: TR9CE4000LCP-Y-MED MODEL:…External battery chargers used with the Version 29 VISTA Negative Pressure Wound Therapy pumps are failing… Smith And Nephew, Inc. Wound Management…08/07/2008Terminated
Z-2168-2008 Suction Jar Lid for Medela Vario 18 Vacuum Pump used with the Bravo pH Monitoring System…The Medela Vario 18 Vacuum Pump used with the Medtronic Bravo pH Monitoring System. The Vacuum Pump is used… Medtronic Neuromodulation04/25/2008Terminated
Z-1620-2008 FLAT DRAIN -10MM, CHARIKER-JETER DRESSING KITS (LARGE AND SMALL) -Product numbers…Incorrect labeling. Kit labels may incorrectly state that a flat drain is contained as a kit component while… Smith And Nephew, Inc. Wound Management…03/31/2008Terminated
Z-0071-2008 NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspiratorFailure of irrigation flow: The pinch valve in a few pumps may not consistently open to allow irrigation… Neomedix Corp05/28/2007Terminated
Z-0035-2007 SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-USFaulty circuit board may short circuit and cause electric shock to operator Haemonetics Corporation07/28/2006Terminated