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 |