FDA Product Code
FDA Product Code MEB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5725
510(k) Clearances — 88 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250234 | SMARTeZ Elastomeric Infusion Pump (RS series) | Epic Medical Pte. , Ltd. | 2026-04-24 | Traditional | PDF ↗ |
| K240624 | InfuLife | First Medical Source, LLC | 2024-11-05 | Traditional | PDF ↗ |
| K242152 | SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) | Epic Medical Pte. , Ltd. | 2024-10-07 | Special | PDF ↗ |
| K181360 | ON-Q* Pump with Bolus | Halyard Health | 2019-03-22 | Traditional | PDF ↗ |
| K151650 | SMARTez elastomeric infusion pump | Epic Medical Pte. , Ltd. | 2016-04-04 | Traditional | PDF ↗ |
| K131249 | ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES | I-Flow, LLC | 2014-02-03 | Traditional | PDF ↗ |
| K131247 | MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM | Mfs - Medical Flow Systems, Ltd. | 2013-08-14 | Traditional | PDF ↗ |
| K090300 | MODIFICATION TO AUTOFUSER | Ace Medical Us, LLC | 2009-04-30 | Special | PDF ↗ |
| K081905 | ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP | Westmed, Inc. | 2008-07-15 | Traditional | PDF ↗ |
| K071532 | ALPHA INFUSION PUMP, MODEL A200, A450 | Advanced Infusion, Inc. | 2008-02-19 | Traditional | PDF ↗ |
| K072921 | DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM | Symbios Medical Products, LLC | 2007-11-26 | Special | PDF ↗ |
| K072053 | SMARTBLOCK PAIN PUMP | Medical Flow Systems, Ltd. | 2007-11-06 | Traditional | PDF ↗ |
| K071735 | MODIFICATION TO DISPOSABLE INFUSION PUMP KIT | Symbios Medical Products, LLC | 2007-07-19 | Special | PDF ↗ |
| K071222 | INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES | Baxter Healthcare Corp | 2007-05-25 | Special | PDF ↗ |
| K063530 | ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP | I-Flow Corp. | 2007-01-26 | Special | PDF ↗ |
| K061661 | STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20 | Advanced Infusion, Inc. | 2006-10-18 | Traditional | PDF ↗ |
| K062457 | INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES | Baxter Healthcare Corporation | 2006-09-21 | Special | PDF ↗ |
| K061409 | SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET | Precise Medical Products, Ltd. | 2006-06-16 | Special | PDF ↗ |
| K060258 | AUTOFUSER | Ace Medical Us, LLC | 2006-05-30 | Traditional | PDF ↗ |
| K060933 | SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM | Apex Medical Technologies, Inc. | 2006-05-09 | Traditional | PDF ↗ |
| K052999 | SEMPERFLO INFUSION SYSTEM | ETHICON, Inc. | 2006-03-22 | Traditional | PDF ↗ |
| K051828 | NIPRO SUREFUSER AMBULATORY INFUSION PUMP | Nipro Medical Corporation | 2005-12-15 | Traditional | PDF ↗ |
| K052451 | MPS ACACIA MEDFLO ELASTOMERIC PUMP | Mps Acacia | 2005-12-08 | Traditional | PDF ↗ |
| K052117 | I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) | I-Flow Corp. | 2005-09-09 | Special | PDF ↗ |
| K051474 | SYMBIOS DISPOSABLE INFUSION PUMP KIT | Symbios Medical Products, LLC | 2005-07-01 | Special | PDF ↗ |
| K050770 | MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT | Mckinley Medical, LLC | 2005-04-14 | Traditional | PDF ↗ |
| K042122 | SMARTINFUSER PAINPUMP | Precise Medical Products | 2004-09-22 | Traditional | PDF ↗ |
| K042246 | MULTI-DRIP INFUSION CATHETER | Advanced Infusion, Inc. | 2004-08-31 | Traditional | PDF ↗ |
| K041585 | AUTOFUSER AMBULATORY INFUSION PUMP | Algos, LC | 2004-08-26 | Traditional | PDF ↗ |
| K040337 | I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP) | I-Flow Corp. | 2004-05-24 | Traditional | PDF ↗ |
| K040752 | DOSI-FUSER | Leventon, S.A. | 2004-04-07 | Traditional | PDF ↗ |
| K033039 | MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS | Mckinley, Inc. | 2003-10-07 | Special | PDF ↗ |
| K030830 | B. BRAUN NERVE BLOCK CATHETER | B.Braun Medical, Inc. | 2003-07-15 | Traditional | PDF ↗ |
| K023883 | HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO | I-Flow Corp. | 2002-12-20 | Special | PDF ↗ |
| K023098 | ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT | Mckinley Infuser | 2002-12-09 | Traditional | PDF ↗ |
| K023318 | I-FLOW ELASTOMERIC PUMP WITH BOLUS | I-Flow Corp. | 2002-10-18 | Special | PDF ↗ |
| K021964 | ALPHA INFUSION PUMP AND CATHETERS | Advanced Infusion, Inc. | 2002-08-12 | Traditional | PDF ↗ |
| K021274 | PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719 | Baxter Healthcare Corp | 2002-05-17 | Traditional | PDF ↗ |
| K020988 | PAIN CARE 4200 | Breg, Inc. | 2002-04-04 | Special | PDF ↗ |
| K020862 | I-FLOW ELASTOMERIC PUMP | I-Flow Corp. | 2002-03-26 | Special | PDF ↗ |
| K020660 | HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO | I-Flow Corp. | 2002-03-20 | Special | PDF ↗ |
| K013928 | PAIN CARE 3200 | Breg, Inc. | 2001-12-03 | Special | PDF ↗ |
| K011117 | MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS | Mps Acacia | 2001-07-09 | Traditional | PDF ↗ |
| K011317 | MULTIRATE INFUSOR SV; MULTIRATE INFUSER LV; BAXTER PAIN MATE PAIN MANAGEMENT SYSTEM | Baxter Healthcare Corp | 2001-06-28 | Traditional | PDF ↗ |
| K010824 | PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT | Science Incorporated | 2001-06-05 | Traditional | PDF ↗ |
| K003915 | ACCUFUSER; ACCUFUSER PLUS | Help Technologies | 2001-02-15 | Traditional | PDF ↗ |
| K003476 | MPS ACACIA PAIN KIT | Mps Acacia | 2001-01-12 | Traditional | PDF ↗ |
| K002073 | PAIN CARE 3000 | Breg, Inc. | 2000-09-19 | Traditional | PDF ↗ |
| K001342 | P.O.P. PAIN KIT | Post Operative Pain Management | 2000-09-07 | Traditional | PDF ↗ |
| K002321 | PAIN CARE 2000L | Breg, Inc. | 2000-08-14 | Special | PDF ↗ |
| K000263 | GO MEDICAL BALLOON INFUSION SYSTEM | Go Medical Industries Pty. , Ltd. | 2000-05-09 | Traditional | PDF ↗ |
| K993832 | AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10 | Tandem Medical, Inc. | 2000-02-09 | Traditional | PDF ↗ |
| K993972 | DISPOSABLE INFUSION PUMP KIT | Biomet, Inc. | 2000-02-07 | Traditional | PDF ↗ |
| K992551 | ALPHA INFUSION PUMP | Advanced Infusion, Inc. | 1999-10-27 | Traditional | PDF ↗ |
| K991543 | INTRAOP CATHETER | I-Flow Corp. | 1999-10-25 | Traditional | PDF ↗ |
| K992015 | FREEDOM INFUSION SYSTEM | Novacon Corp. | 1999-09-10 | Traditional | PDF ↗ |
| K990461 | MCKINLEY SP DISPOSABLE INFUSION PUMP | Mckinley, Inc. | 1999-06-30 | Traditional | PDF ↗ |
| K990889 | AUTODOSE INFUSION SYSTEM | Tandem Medical, Inc. | 1999-06-03 | Traditional | PDF ↗ |
| K984502 | NERVE BLOCK INFUSION KIT | I-Flow Corp. | 1999-03-04 | Traditional | PDF ↗ |
| K983634 | PREPARE HOME INFUSION PUMP | Medical Infusion Technologies, Inc. | 1999-02-24 | Traditional | PDF ↗ |
| K983454 | PAIN CARE 2000 | Breg, Inc. | 1998-12-16 | Traditional | PDF ↗ |
| K982946 | PAINBUSTER INFUSION KIT | I-Flow Corp. | 1998-11-18 | Traditional | PDF ↗ |
| K982256 | OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP | Mckinley, Inc. | 1998-09-30 | Traditional | PDF ↗ |
| K982102 | SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY | Baxter Healthcare Corp | 1998-09-04 | Traditional | PDF ↗ |
| K980558 | PAINBUSTER INFUSION SYSTEM | I-Flow Corp. | 1998-05-28 | Traditional | PDF ↗ |
| K972158 | GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES | Princeton Regulatory Assoc. | 1998-02-20 | Traditional | PDF ↗ |
| K971362 | PERSONAL INFUSOR | Science Incorporated | 1997-12-04 | Traditional | PDF ↗ |
| K972173 | MEDI-SIS SYRINGE INFUSION SYSTEM | I-Flow Corp. | 1997-08-15 | Traditional | PDF ↗ |
| K971168 | ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE | Baxter Healthcare Corp | 1997-07-15 | Traditional | PDF ↗ |
| K965222 | MICROJECT MODEL PCA-1 | Microject, Inc. | 1997-06-19 | Traditional | PDF ↗ |
| K963355 | SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET | Solopak Medical Products, Inc. | 1996-10-04 | Traditional | PDF ↗ |
| K962663 | SOLOPAK SIDEKICK INFUSION PUMP AND ADMINISTATION SET | Solopak Medical Products, Inc. | 1996-10-04 | Traditional | PDF ↗ |
| K955849 | DIB INFUSOR | Novacon Corp. | 1996-08-05 | Traditional | PDF ↗ |
| K960318 | DIB INFUSOR-RA | Novacon Corp. | 1996-08-05 | Traditional | PDF ↗ |
| K955727 | BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET | I-Flow Corp. | 1996-02-08 | Traditional | PDF ↗ |
| K954059 | TITAN 20 CC DRIVER | I-Flow Corp. | 1995-09-29 | Traditional | PDF ↗ |
| K953028 | TITAN DRIVER 60CC, 30 MINUTE ADMINISTRATION SET | I-Flow Corp. | 1995-09-28 | Traditional | PDF ↗ |
| K941418 | INFUSION PUMP | I-Flow Corp. | 1995-07-18 | Traditional | PDF ↗ |
| K944665 | DIB INFUSORS | Novacon Corp. | 1995-02-14 | Traditional | PDF ↗ |
| K943664 | INTERMATE XLV ELASTOMERIC INFUSION SYSTEM | Baxter Healthcare Corp | 1994-11-03 | Traditional | PDF ↗ |
| K940406 | DISPOSABLE, AMBULATORY, INFUSION PUMPS | Vlv Associates, Inc. | 1994-09-02 | Traditional | PDF ↗ |
| K941766 | DIB INFUSOR | Novacon Corp. | 1994-08-05 | Traditional | PDF ↗ |
| K940117 | MID-500 | Block Medical, Inc. | 1994-06-10 | Traditional | PDF ↗ |
| K930404 | DIB INFUSOR | Novacon Corp. | 1994-02-25 | Traditional | PDF ↗ |
| K922382 | INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE | Baxter Healthcare Corp | 1993-02-05 | Traditional | PDF ↗ |
| K914148 | PRIME CADI-120 | Prime Medical Products, Inc. | 1992-10-05 | Traditional | PDF ↗ |
| K911636 | GENESIS(TM) INFUSION SYSTEM | Norman'S | 1992-07-17 | Traditional | PDF ↗ |
| K913658 | IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD | Imed Corp. | 1992-03-26 | Traditional | PDF ↗ |
Product code MEB · Class II · General Hospital. Data: openFDA.