FDA 510(k) Applications for Medical Device Product Code "BTA"
(Pump, Portable, Aspiration (Manual Or Powered))

FDA 510(k) Number Applicant Device Name Decision Date
K832100 ADVANCED BIOSEARCH ASSN. PSI SURGICAL ASPIRATOR 10/04/1983
K954287 ADVANCED CYTOMETRIX, INC. ACI FINE NEEDLE ASPIRATION BIOPSY KIT 11/29/1995
K954286 ADVANCED CYTOMETRIX, INC. ACI PULSATING VACUUM PUMP SYSTEM 11/29/1995
K954264 ADVANCED CYTOMETRIX, INC. ACI SINGLE LUMEN BIOPSY NEEDLE 11/29/1995
K952103 AEROS INSTRUMENTS, INC. AEROS ASPIRATOR 07/31/1995
K926566 AEROS INSTRUMENTS, INC. CARE-E-VAC 07/09/1993
K934976 AEROS INSTRUMENTS, INC. INSTAVAC II 05/02/1994
K933902 AEROS INSTRUMENTS, INC. MOBLVAC III 05/20/1994
K932051 AEROS INSTRUMENTS, INC. TOTE-L-VAC 11/12/1993
K873940 AESTHETECH CORP. CREAT BRAND O-RISE GENERAL ASPIRATOR 11/25/1987
K971107 ALEXANDER MFG. CO. ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5 06/05/1997
K810490 ALLIED HEALTHCARE PRODUCTS, INC. GOMCO SUCTION PUMP CABINET CHANGE 03/13/1981
K932031 AMBU, INC. AMBU PORTABLE SUCTION UNIT 05/05/1995
K871570 APEX MEDICAL, INC. APEX ALPHA VACUUM PUMP 08/18/1987
K122619 APPLIED MEDICAL EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET 10/02/2012
K011601 ARDO MEDICAL AG ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX 06/08/2001
K090445 ATMOS INC. ATMOS C361/C451 SUCTION PUMP 02/27/2009
K103042 ATMOS INC. ATMOS E 201 THORAX AND ATMOS S 201 THORAX 04/15/2011
K130131 ATRIUM MEDICAL CORP. EDRAIN CHEST DRAINAGE SYSTEM 02/28/2013
K090379 AVITA CORPORATION AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES 05/26/2010
K951326 BIOPSYS MEDICAL, INC. BIOPSY DEVICE ACCESSORY 05/15/1995
K980392 BYRON MEDICAL PSI-TEC ASPIRATOR 03/05/1998
K944818 COOK UROLOGICAL, INC. COOK ASPIRATION/IRRIGATION UNIT 11/08/1994
K842204 DEAN MEDICAL INSTRUMENTS, INC. DMI ASPIRATOR 500 08/10/1984
K853917 EGNELL, INC. EGNELL COMPACT SUCTION PUMP 11/25/1985
K812020 EGNELL, INC. EGNELL COMPACT, TYPE EHV 10/20/1981
K853909 EGNELL, INC. EGNELL UNIVERSAL SUCTION PUMP 11/25/1985
K813095 EGNELL, INC. GASTRIC JUICES SUCTION PUMP 12/09/1981
K813312 EGNELL, INC. UNIVERSAL SUCTION PUMP TYPE EUS 12/31/1981
K854844 ENGINEERING, INC. LS1000 SURGICAL ASPIRATOR II 02/12/1986
K013116 EVER-SAFETY TECHNICAL SERVICE DURQ/ QUALIDURA 01/18/2002
K841903 FRASER HARLAKE, INC. FRASER HARLAKE EMERG. CARE SUCTION SYS 06/14/1984
K080745 GENADYNE BIOTECHNOLOGIES, INC. GENADYNE A4 POWERED SUCTION PUMP 07/30/2008
K970186 GI SUPPLY GI SUPPLY PARACENTESIS PUMP 02/14/1997
K840803 GRAMS MEDICAL INC. GRAMS ASPIRATOR S-300 05/21/1984
K843750 H.C.H. PRODUCTS, INC. APPARATUS, SUCTION, WARD USE, PORTAB- 10/11/1984
K852646 H.C.H. PRODUCTS, INC. THERMATIC SUCTION PUMP 08/15/1985
K052626 HAEMONETICS CORP. SMARTSUCTION HARMONY DEVICE 10/05/2005
K062801 HAEMONETICS CORP. SMARTSUCTION SOLO DEVICE 10/04/2006
K093241 HERSILL, S.L. V7 PORTABLE SUCTION UNITS 04/27/2010
K960492 I.C. MEDICAL, INC. SI CONTROLLER MODEL SI 500 12/23/1996
K951423 IMPACT INSTRUMENTATION, INC. ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT 04/18/1995
K941096 IMPACT INSTRUMENTATION, INC. ELECTRIC VACUM PUMP 01/05/1995
K820338 IMPACT INSTRUMENTATION, INC. IMPACT, MODELS 306/307 03/02/1982
K041405 INDUSTRIAL & MEDICAL DESIGN, INC. ASPIRATION PUMP, MODEL IMD-020 09/02/2004
K843693 J. SKLAR MFG. CO., INC. JACOBS HIGH VACUUM SUCTION UNIT 05-2570 10/31/1984
K862569 JEDMED INSTRUMENT CO. HEAVY DUTY (HD) SUCTION UNITS (W/CANNULAS) 08/14/1986
K910271 JEDMED INSTRUMENT CO. VACPAC PORTABLE ASPIRATION SYSTEM 03/20/1991
K981703 KARL STORZ ENDOSCOPY KSEA UNIMAT 45 08/12/1998
K953132 KARL STORZ ENDOSCOPY-AMERICA, INC. UIMAT PUMP 08/23/1995
K841399 KEYMED, INC. BRONCHOSCOPE SUCTION UNIT 07/18/1984
K820739 KEYMED, INC. KEYMED KEY VAC SUCTION PUMP 05/21/1982
K844200 KM PRODUCTS K.M. PRODUCTS ASPIRATOR 01/25/1985
K862875 LAERDAL CALIFORNIA, INC. E-VAC(TM) 11/03/1986
K941578 LAERDAL CALIFORNIA, INC. STATVAC PORTABLE SUCTION UNIT 05/18/1994
K993668 LAERDAL MEDICAL A/S LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 12/20/1999
K840110 LAERDAL MEDICAL CORP. LAERDAL SUCTION UNIT 03/12/1984
K874157 LASE, INC. LASE EVACUATOR/ASPIRATOR 03/21/1988
K921107 LIFE SUPPORT PRODUCTS, INC. AUTOVAC 09/17/1992
K940934 LIFE SUPPORT PRODUCTS, INC. LIFE VAC 05/03/1994
K980454 LYSONIX, INC. LYSONIX ASPIRATION PUMP 03/18/1998
K921611 MADA MEDICAL PRODUCTS, INC. MADAVAC 190 09/09/1992
K092903 MAQUET GMBH AND CO. KG "BORA UP 2080", BORA UP 2080 OP" AND "BORA UP 2080 MOUNTING" 12/01/2009
K982371 MEDCO MFG. MEDCO ASPIRATOR IV 02/12/1999
K130123 MEDELA AG BASIC AND DOMINANT FLEX SUCTION PUMPS 10/11/2013
K150134 MEDELA AG Basic, Dominant Flex, KV-6 4/21/2015
K021368 MEDELA AG MEDELA "BASIC 30" AND "DOMINANT 50" SUCTION PUMPS, MODELS 037, 057 05/15/2002
K033179 MEDELA AG MEDELA CLARIO HOME CARE PUMP 10/15/2003
K043544 MEDELA AG MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR 01/07/2005
K130210 MEDELA AG MEDELA THOPAZ 03/15/2013
K141553 MEDELA AG MEDELA THOPAZ+ 8/25/2014
K080212 MEDELA AG MEDELA THOPAZ, MODEL 200 0288 07/23/2008
K061205 MEDELA AG MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR 06/21/2006
K983552 MEDELA, INC. BASIC, MEDIAN, DOMINANT, AND VARIO 01/07/1999
K941961 MEDICAL INDUSTRIES AMERICA, INC. 605 VACU-MAX 03/02/1995
K963775 MEDICAL SPECIFICS, INC. MODEL 8800 ASPIRATOR 03/26/1997
K850946 MEDICALEX SURGICAL ASPIRATOR 09/16/1985
K831007 MEDOVATIONS, INC. CONNECTING TUBES 05/18/1983
K052650 MERITS HEALTH PRODUCTS CO., LTD. PIONEER U601 SERIES ASPIRATOR 11/04/2005
K973268 MICROAIRE SURGICAL INSTRUMENTS, INC. MICROAIRE "POWER ASPIRATION DEVICE" PAD SYSTEM 11/26/1997
K040239 NEOMEDIX CORP. SUPRAFLOW CONSOLE 02/17/2004
K042943 NOUVAG AG NOUVAG AG - VACUSON 40 AND VACUSON 60 12/17/2004
K061133 NOVASPINE LLC SIMEX SUCTION PUMP, MODELS AC20, AC20K, AC30, DC20, DC30 AND DC30S 07/11/2006
K062610 OHIO MEDICAL CORPORATION CARE-E-VAC 3 09/28/2006
K081185 OHIO MEDICAL CORPORATION MOBLVAC W.C. 05/02/2008
K051758 PENUMBRA, INC. PENUMBRA ASPIRATION PUMP, MODEL 115V 08/17/2005
K931348 PORTABLE POWER SYSTEMS, INC. BATTERY PACK #1005NC 02/17/1994
K140179 PRECISION MEDICAL, INC. EASY GO VAC 04/25/2014
K971749 PRECISION MEDICAL, INC. EASYGO ASPIRATOR 04/01/1998
K932494 PRECISION MEDICAL, INC. PM PUMP ASPIRATOR 10/07/1993
K942033 R & D BATTERIES, INC. R&D BATTERIES, PART NOS. 5243, 5104, AND 5481 06/28/1994
K920628 RECTO MOLDED PRODUCTS, INC. QUINEVAC EVACUATOR/ASPIRATOR 03/23/1993
K851560 ROSEBURG SA PORTASPIR II 12/13/1985
K980301 SERVIZI MEDICO ESTETICI ITALINAI SRL. IP-16 03/24/1998
K013585 SERVOX MEDIZINTECHNIK GMBH MEDIPORT 2000 MOBILE 01/28/2002
K141255 SIMEX MEDIZINTECHNIK GMBH SIMEX SUBGLOTTIC ASPIRATION SYSTEM 9/22/2014
K922176 SMITH & NEPHEW DYONICS, INC. INTELIJET SUCTION SUPPLY 11/18/1992
K821321 SNYDER LABORATORIES, INC. SNYDER DEBRIBEMENT SYSTEM LDP-1 08/06/1982
K992026 SORING GMBH MEDIZINTECHNIK SORING GMBH, SONOCA 300 09/23/1999
K952632 SSCOR S-SCORT 06/16/1995
K964997 SSCOR S-SCORT (2500) 03/05/1997
K945929 SSCOR S-SCORT(R)DUET MODEL 2014 PORTABLE SUCTION PUMP 12/22/1994
K041154 SSCOR S-SCORT...JR QUICKDRAW, MODEL 2400 05/18/2004
K944116 STACKHOUSE, INC. FREEDOM ASPIRATOR, MODEL 6000 09/07/1994
K843644 STORZ INSTRUMENT CO. STORZ ASPIRATION MACHINE SAM 5000 11/16/1984
K791349 STRYKER CORP. SYSTEC 280 INTEGRATED SUCTION SYSTEM 09/07/1979
K981602 SUNRISE MEDICAL HHG, INC. DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR 07/17/1998
K950495 SURGICAL DYNAMICS, INC. SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000 05/09/1995
K860030 SURGIDYNE, INC. SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID 02/12/1986
K883582 SURGIDYNE, INC. VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM 10/03/1988
K831085 SYNEMED, INC. SYNEVAC VACUUM SOURCE UNIT 06/08/1983
K870094 THE JOHN BUNN CO. BUNN MODEL 530 ASPIRATOR 03/06/1987
K965059 THOMAS INDUSTRIES CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243) 03/04/1997
K951729 THOMAS INDUSTRIES MEDI - PUMP 08/21/1995
K952806 THOMAS INDUSTRIES MEDI PUMP ASPIRATOR MODELS 1130 AND 1135 10/26/1995
K944399 THOMAS INDUSTRIES MEDI-PUMP 01/18/1995
K041199 THOMAS INDUSTRIES MEDI-PUMP ASPIRATOR, MODEL 1615 06/01/2004
K862751 U. S. A. MEDICAL CORP. USA ASPIRATOR 08/04/1986
K891129 ULTRAVAC, INC. SERIES 3 GENERAL SUCTION SYSTEM 09/25/1989
K873462 VAN DELLEN, LTD. VAN DELLEN ASPIRATOR 09/25/1987
K833785 VITALOGRAPH LTD. EMERGENCY ASPIRATOR 12/22/1983
K832274 WELLS JOHNSON CO. ASPIRATOR 10/20/1983
K933757 XIMED MEDICAL SYSTEMS HAND-HELD IRRIGATION PUMP 08/26/1994
K984363 XOMED, INC. XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM 02/26/1999
K071607 ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. ASA01 HEAVY DUTY SUCTION PUMP 06/26/2007


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