FDA 510(k) Applications for Medical Device Product Code "MEB"
(Pump, Infusion, Elastomeric)

FDA 510(k) Number Applicant Device Name Decision Date
K060258 ACE MEDICAL US, LLC AUTOFUSER 05/30/2006
K090300 ACE MEDICAL US, LLC MODIFICATION TO AUTOFUSER 04/30/2009
K992551 ADVANCED INFUSION, INC. ALPHA INFUSION PUMP 10/27/1999
K021964 ADVANCED INFUSION, INC. ALPHA INFUSION PUMP AND CATHETERS 08/12/2002
K071532 ADVANCED INFUSION, INC. ALPHA INFUSION PUMP, MODEL A200, A450 02/19/2008
K042246 ADVANCED INFUSION, INC. MULTI-DRIP INFUSION CATHETER 08/31/2004
K061661 ADVANCED INFUSION, INC. STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20 10/18/2006
K041585 ALGOS, LC AUTOFUSER AMBULATORY INFUSION PUMP 08/26/2004
K060933 APEX MEDICAL TECHNOLOGIES, INC. SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM 05/09/2006
K030830 B. BRAUN MEDICAL, INC. B. BRAUN NERVE BLOCK CATHETER 07/15/2003
K071222 BAXTER HEALTHCARE CORP. INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES 05/25/2007
K011317 BAXTER HEALTHCARE CORP. MULTIRATE INFUSOR SV; MULTIRATE INFUSER LV; BAXTER PAIN MATE PAIN MANAGEMENT SYSTEM 06/28/2001
K971168 BAXTER HEALTHCARE CORP. ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE 07/15/1997
K021274 BAXTER HEALTHCARE CORP. PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719 05/17/2002
K982102 BAXTER HEALTHCARE CORP. SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY 09/04/1998
K062457 BAXTER HEALTHCARE CORPORATION INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES 09/21/2006
K993972 BIOMET, INC. DISPOSABLE INFUSION PUMP KIT 02/07/2000
K983454 BREG, INC. PAIN CARE 2000 12/16/1998
K002321 BREG, INC. PAIN CARE 2000L 08/14/2000
K002073 BREG, INC. PAIN CARE 3000 09/19/2000
K013928 BREG, INC. PAIN CARE 3200 12/03/2001
K020988 BREG, INC. PAIN CARE 4200 04/04/2002
K151650 Epic Medical Pte Ltd SMARTez elastomeric infusion pump 04/04/2016
K052999 ETHICON, INC. SEMPERFLO INFUSION SYSTEM 03/22/2006
K000263 GO MEDICAL INDUSTRIES PTY. LTD. GO MEDICAL BALLOON INFUSION SYSTEM 05/09/2000
K181360 Halyard Health ON-Q* Pump with Bolus 03/22/2019
K003915 HELPTECHNOLOGIES ACCUFUSER; ACCUFUSER PLUS 02/15/2001
K955727 I-FLOW CORP. BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET 02/08/1996
K023883 I-FLOW CORP. HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO 12/20/2002
K020660 I-FLOW CORP. HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO 03/20/2002
K020862 I-FLOW CORP. I-FLOW ELASTOMERIC PUMP 03/26/2002
K040337 I-FLOW CORP. I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP) 05/24/2004
K052117 I-FLOW CORP. I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) 09/09/2005
K023318 I-FLOW CORP. I-FLOW ELASTOMERIC PUMP WITH BOLUS 10/18/2002
K991543 I-FLOW CORP. INTRAOP CATHETER 10/25/1999
K972173 I-FLOW CORP. MEDI-SIS SYRINGE INFUSION SYSTEM 08/15/1997
K984502 I-FLOW CORP. NERVE BLOCK INFUSION KIT 03/04/1999
K063530 I-FLOW CORP. ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP 01/26/2007
K982946 I-FLOW CORP. PAINBUSTER INFUSION KIT 11/18/1998
K980558 I-FLOW CORP. PAINBUSTER INFUSION SYSTEM 05/28/1998
K131249 I-FLOW LLC ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES 02/03/2014
K040752 LEVENTON, S.A. DOSI-FUSER 04/07/2004
K023098 MCKINLEY INFUSER ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT 12/09/2002
K050770 MCKINLEY MEDICAL LLC MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT 04/14/2005
K990461 MCKINLEY, INC. MCKINLEY SP DISPOSABLE INFUSION PUMP 06/30/1999
K033039 MCKINLEY, INC. MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS 10/07/2003
K982256 MCKINLEY, INC. OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP 09/30/1998
K072053 MEDICAL FLOW SYSTEMS LTD SMARTBLOCK PAIN PUMP 11/06/2007
K983634 MEDICAL INFUSION TECHNOLOGIES, INC. PREPARE HOME INFUSION PUMP 02/24/1999
K131247 MFS - MEDICAL FLOW SYSTEMS LTD MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM 08/14/2013
K965222 MICROJECT, INC. MICROJECT MODEL PCA-1 06/19/1997
K052451 MPS ACACIA MPS ACACIA MEDFLO ELASTOMERIC PUMP 12/08/2005
K011117 MPS ACACIA MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS 07/09/2001
K003476 MPS ACACIA MPS ACACIA PAIN KIT 01/12/2001
K051828 NIPRO MEDICAL CORPORATION NIPRO SUREFUSER AMBULATORY INFUSION PUMP 12/15/2005
K955849 NOVACON CORP. DIB INFUSOR 08/05/1996
K960318 NOVACON CORP. DIB INFUSOR-RA 08/05/1996
K992015 NOVACON CORP. FREEDOM INFUSION SYSTEM 09/10/1999
K001342 POST OPERATIVE PAIN MANAGEMENT P.O.P. PAIN KIT 09/07/2000
K042122 PRECISE MEDICAL PRODUCTS SMARTINFUSER PAINPUMP 09/22/2004
K061409 PRECISE MEDICAL PRODUCTS, LTD. SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET 06/16/2006
K972158 PRINCETON REGULATORY ASSOC. GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES 02/20/1998
K971362 SCIENCE INCORPORATED PERSONAL INFUSOR 12/04/1997
K010824 SCIENCE INCORPORATED PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT 06/05/2001
K963355 SOLOPAK MEDICAL PRODUCTS, INC. SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET 10/04/1996
K962663 SOLOPAK MEDICAL PRODUCTS, INC. SOLOPAK SIDEKICK INFUSION PUMP AND ADMINISTATION SET 10/04/1996
K072921 SYMBIOS MEDICAL PRODUCTS, LLC DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM 11/26/2007
K071735 SYMBIOS MEDICAL PRODUCTS, LLC MODIFICATION TO DISPOSABLE INFUSION PUMP KIT 07/19/2007
K051474 SYMBIOS MEDICAL PRODUCTS, LLC SYMBIOS DISPOSABLE INFUSION PUMP KIT 07/01/2005
K990889 TANDEM MEDICAL, INC. AUTODOSE INFUSION SYSTEM 06/03/1999
K993832 TANDEM MEDICAL, INC. AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10 02/09/2000
K081905 Westmed, Inc. ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP 07/15/2008


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