| SMARTeZ™ Elastomeric Infusion Pump (RS series) (K250234) | Epic Medical Pte. , Ltd. | 2026-04-24 |
| InfuLife (K240624) | First Medical Source, LLC | 2024-11-05 |
| SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) (K242152) | Epic Medical Pte. , Ltd. | 2024-10-07 |
| ON-Q* Pump with Bolus (K181360) | Halyard Health | 2019-03-22 |
| SMARTez elastomeric infusion pump (K151650) | Epic Medical Pte. , Ltd. | 2016-04-04 |
| ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES (K131249) | I-Flow, LLC | 2014-02-03 |
| MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM (K131247) | Mfs - Medical Flow Systems, Ltd. | 2013-08-14 |
| MODIFICATION TO AUTOFUSER (K090300) | Ace Medical Us, LLC | 2009-04-30 |
| ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP (K081905) | Westmed, Inc. | 2008-07-15 |
| ALPHA INFUSION PUMP, MODEL A200, A450 (K071532) | Advanced Infusion, Inc. | 2008-02-19 |
| DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM (K072921) | Symbios Medical Products, LLC | 2007-11-26 |
| SMARTBLOCK PAIN PUMP (K072053) | Medical Flow Systems, Ltd. | 2007-11-06 |
| MODIFICATION TO DISPOSABLE INFUSION PUMP KIT (K071735) | Symbios Medical Products, LLC | 2007-07-19 |
| INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES (K071222) | Baxter Healthcare Corp | 2007-05-25 |
| ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP (K063530) | I-Flow Corp. | 2007-01-26 |
| STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20 (K061661) | Advanced Infusion, Inc. | 2006-10-18 |
| INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES (K062457) | Baxter Healthcare Corporation | 2006-09-21 |
| SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET (K061409) | Precise Medical Products, Ltd. | 2006-06-16 |
| AUTOFUSER (K060258) | Ace Medical Us, LLC | 2006-05-30 |
| SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM (K060933) | Apex Medical Technologies, Inc. | 2006-05-09 |
| SEMPERFLO INFUSION SYSTEM (K052999) | ETHICON, Inc. | 2006-03-22 |
| NIPRO SUREFUSER AMBULATORY INFUSION PUMP (K051828) | Nipro Medical Corporation | 2005-12-15 |
| MPS ACACIA MEDFLO ELASTOMERIC PUMP (K052451) | Mps Acacia | 2005-12-08 |
| I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) (K052117) | I-Flow Corp. | 2005-09-09 |
| SYMBIOS DISPOSABLE INFUSION PUMP KIT (K051474) | Symbios Medical Products, LLC | 2005-07-01 |
| MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT (K050770) | Mckinley Medical, LLC | 2005-04-14 |
| SMARTINFUSER PAINPUMP (K042122) | Precise Medical Products | 2004-09-22 |
| MULTI-DRIP INFUSION CATHETER (K042246) | Advanced Infusion, Inc. | 2004-08-31 |
| AUTOFUSER AMBULATORY INFUSION PUMP (K041585) | Algos, LC | 2004-08-26 |
| I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP) (K040337) | I-Flow Corp. | 2004-05-24 |
| DOSI-FUSER (K040752) | Leventon, S.A. | 2004-04-07 |
| MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS (K033039) | Mckinley, Inc. | 2003-10-07 |
| B. BRAUN NERVE BLOCK CATHETER (K030830) | B.Braun Medical, Inc. | 2003-07-15 |
| HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO (K023883) | I-Flow Corp. | 2002-12-20 |
| ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT (K023098) | Mckinley Infuser | 2002-12-09 |
| I-FLOW ELASTOMERIC PUMP WITH BOLUS (K023318) | I-Flow Corp. | 2002-10-18 |
| ALPHA INFUSION PUMP AND CATHETERS (K021964) | Advanced Infusion, Inc. | 2002-08-12 |
| PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719 (K021274) | Baxter Healthcare Corp | 2002-05-17 |
| PAIN CARE 4200 (K020988) | Breg, Inc. | 2002-04-04 |
| I-FLOW ELASTOMERIC PUMP (K020862) | I-Flow Corp. | 2002-03-26 |
| HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO (K020660) | I-Flow Corp. | 2002-03-20 |
| PAIN CARE 3200 (K013928) | Breg, Inc. | 2001-12-03 |
| MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS (K011117) | Mps Acacia | 2001-07-09 |
| MULTIRATE INFUSOR SV; MULTIRATE INFUSER LV; BAXTER PAIN MATE PAIN MANAGEMENT SYSTEM (K011317) | Baxter Healthcare Corp | 2001-06-28 |
| PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT (K010824) | Science Incorporated | 2001-06-05 |
| ACCUFUSER; ACCUFUSER PLUS (K003915) | Help Technologies | 2001-02-15 |
| MPS ACACIA PAIN KIT (K003476) | Mps Acacia | 2001-01-12 |
| PAIN CARE 3000 (K002073) | Breg, Inc. | 2000-09-19 |
| P.O.P. PAIN KIT (K001342) | Post Operative Pain Management | 2000-09-07 |
| PAIN CARE 2000L (K002321) | Breg, Inc. | 2000-08-14 |
| GO MEDICAL BALLOON INFUSION SYSTEM (K000263) | Go Medical Industries Pty. , Ltd. | 2000-05-09 |
| AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10 (K993832) | Tandem Medical, Inc. | 2000-02-09 |
| DISPOSABLE INFUSION PUMP KIT (K993972) | Biomet, Inc. | 2000-02-07 |
| ALPHA INFUSION PUMP (K992551) | Advanced Infusion, Inc. | 1999-10-27 |
| INTRAOP CATHETER (K991543) | I-Flow Corp. | 1999-10-25 |
| FREEDOM INFUSION SYSTEM (K992015) | Novacon Corp. | 1999-09-10 |
| MCKINLEY SP DISPOSABLE INFUSION PUMP (K990461) | Mckinley, Inc. | 1999-06-30 |
| AUTODOSE INFUSION SYSTEM (K990889) | Tandem Medical, Inc. | 1999-06-03 |
| NERVE BLOCK INFUSION KIT (K984502) | I-Flow Corp. | 1999-03-04 |
| PREPARE HOME INFUSION PUMP (K983634) | Medical Infusion Technologies, Inc. | 1999-02-24 |
| PAIN CARE 2000 (K983454) | Breg, Inc. | 1998-12-16 |
| PAINBUSTER INFUSION KIT (K982946) | I-Flow Corp. | 1998-11-18 |
| OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP (K982256) | Mckinley, Inc. | 1998-09-30 |
| SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY (K982102) | Baxter Healthcare Corp | 1998-09-04 |
| PAINBUSTER INFUSION SYSTEM (K980558) | I-Flow Corp. | 1998-05-28 |
| GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES (K972158) | Princeton Regulatory Assoc. | 1998-02-20 |
| PERSONAL INFUSOR (K971362) | Science Incorporated | 1997-12-04 |
| MEDI-SIS SYRINGE INFUSION SYSTEM (K972173) | I-Flow Corp. | 1997-08-15 |
| ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE (K971168) | Baxter Healthcare Corp | 1997-07-15 |
| MICROJECT MODEL PCA-1 (K965222) | Microject, Inc. | 1997-06-19 |
| SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET (K963355) | Solopak Medical Products, Inc. | 1996-10-04 |
| SOLOPAK SIDEKICK INFUSION PUMP AND ADMINISTATION SET (K962663) | Solopak Medical Products, Inc. | 1996-10-04 |
| DIB INFUSOR (K955849) | Novacon Corp. | 1996-08-05 |
| DIB INFUSOR-RA (K960318) | Novacon Corp. | 1996-08-05 |
| BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET (K955727) | I-Flow Corp. | 1996-02-08 |
| TITAN 20 CC DRIVER (K954059) | I-Flow Corp. | 1995-09-29 |
| TITAN DRIVER 60CC, 30 MINUTE ADMINISTRATION SET (K953028) | I-Flow Corp. | 1995-09-28 |
| INFUSION PUMP (K941418) | I-Flow Corp. | 1995-07-18 |
| DIB INFUSORS (K944665) | Novacon Corp. | 1995-02-14 |
| INTERMATE XLV ELASTOMERIC INFUSION SYSTEM (K943664) | Baxter Healthcare Corp | 1994-11-03 |
| DISPOSABLE, AMBULATORY, INFUSION PUMPS (K940406) | Vlv Associates, Inc. | 1994-09-02 |
| DIB INFUSOR (K941766) | Novacon Corp. | 1994-08-05 |
| MID-500 (K940117) | Block Medical, Inc. | 1994-06-10 |
| DIB INFUSOR (K930404) | Novacon Corp. | 1994-02-25 |
| INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE (K922382) | Baxter Healthcare Corp | 1993-02-05 |
| PRIME CADI-120 (K914148) | Prime Medical Products, Inc. | 1992-10-05 |
| GENESIS(TM) INFUSION SYSTEM (K911636) | Norman'S | 1992-07-17 |
| IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD (K913658) | Imed Corp. | 1992-03-26 |