Panels › General Hospital › Product code MEB · Class 2
Pump, Infusion, Elastomeric
Regulation 880.5725
1510(k)s in 12 months (88 all time)
0recalls in 12 months (109 all time)
94recalls that name a 510(k)
Top companies in MEB
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Instruments Div. of Stryker Corporation | 0 | 46 |
| I-Flow Corp. | 17 | 11 |
| Baxter Healthcare Corp | 8 | 10 |
| Arrow International Inc | 0 | 17 |
| Symbios Medical Products, LLC | 3 | 12 |
| Novacon Corp. | 6 | 0 |
| Advanced Infusion, Inc. | 5 | 0 |
| Breg, Inc. | 5 | 0 |
| Hsmg, Inc. D/b/a Smartinfuser Usa | 0 | 4 |
| B.Braun Medical, Inc. | 1 | 2 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 24, 2026 | K250234 | SMARTeZ Elastomeric Infusion Pump (RS series) Epic Medical Pte. , Ltd., SG | MEB |
| Nov 5, 2024 | K240624 | InfuLife First Medical Source, LLC | MEB |
| Oct 7, 2024 | K242152 | SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) Epic Medical Pte. , Ltd., SG | MEB |
| Mar 22, 2019 | K181360 | ON-Q* Pump with Bolus Halyard Health | MEB |
| Apr 4, 2016 | K151650 | SMARTez elastomeric infusion pump Epic Medical Pte. , Ltd., SG | MEB |
| Feb 3, 2014 | K131249 | ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES I-Flow, LLC | MEB |
| Aug 14, 2013 | K131247 | MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM Mfs - Medical Flow Systems, Ltd., IL | MEB |
| Apr 30, 2009 | K090300 | MODIFICATION TO AUTOFUSER Ace Medical Us, LLC | MEB |
| Jul 15, 2008 | K081905 | ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP Westmed, Inc. | MEB |
| Feb 19, 2008 | K071532 | ALPHA INFUSION PUMP, MODEL A200, A450 Advanced Infusion, Inc. | MEB |
| Nov 26, 2007 | K072921 | DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM Symbios Medical Products, LLC | MEB |
| Nov 6, 2007 | K072053 | SMARTBLOCK PAIN PUMP Medical Flow Systems, Ltd. | MEB |
| Jul 19, 2007 | K071735 | MODIFICATION TO DISPOSABLE INFUSION PUMP KIT Symbios Medical Products, LLC | MEB |
| May 25, 2007 | K071222 | INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES Baxter Healthcare Corp | MEB |
| Jan 26, 2007 | K063530 | ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP I-Flow Corp. | MEB |
| Oct 18, 2006 | K061661 | STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20 Advanced Infusion, Inc. | MEB |
| Sep 21, 2006 | K062457 | INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES Baxter Healthcare Corporation | MEB |
| Jun 16, 2006 | K061409 | SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET Precise Medical Products, Ltd., IL | MEB |
| May 30, 2006 | K060258 | AUTOFUSER Ace Medical Us, LLC | MEB |
| May 9, 2006 | K060933 | SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM Apex Medical Technologies, Inc. | MEB |
| Mar 22, 2006 | K052999 | SEMPERFLO INFUSION SYSTEM ETHICON, Inc. | MEB |
| Dec 15, 2005 | K051828 | NIPRO SUREFUSER AMBULATORY INFUSION PUMP Nipro Medical Corporation | MEB |
| Dec 8, 2005 | K052451 | MPS ACACIA MEDFLO ELASTOMERIC PUMP Mps Acacia | MEB |
| Sep 9, 2005 | K052117 | I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) I-Flow Corp. | MEB |
| Jul 1, 2005 | K051474 | SYMBIOS DISPOSABLE INFUSION PUMP KIT Symbios Medical Products, LLC | MEB |
| Apr 14, 2005 | K050770 | MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT Mckinley Medical, LLC | MEB |
| Sep 22, 2004 | K042122 | SMARTINFUSER PAINPUMP Precise Medical Products, IL | MEB |
| Aug 31, 2004 | K042246 | MULTI-DRIP INFUSION CATHETER Advanced Infusion, Inc. | MEB |
| Aug 26, 2004 | K041585 | AUTOFUSER AMBULATORY INFUSION PUMP Algos, LC | MEB |
| May 24, 2004 | K040337 | I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP) I-Flow Corp. | MEB |
| Apr 7, 2004 | K040752 | DOSI-FUSER Leventon, S.A., ES | MEB |
| Oct 7, 2003 | K033039 | MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS Mckinley, Inc. | MEB |
| Jul 15, 2003 | K030830 | B. BRAUN NERVE BLOCK CATHETER B.Braun Medical, Inc. | MEB |
| Dec 20, 2002 | K023883 | HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO I-Flow Corp. | MEB |
| Dec 9, 2002 | K023098 | ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT Mckinley Infuser | MEB |
| Oct 18, 2002 | K023318 | I-FLOW ELASTOMERIC PUMP WITH BOLUS I-Flow Corp. | MEB |
| Aug 12, 2002 | K021964 | ALPHA INFUSION PUMP AND CATHETERS Advanced Infusion, Inc. | MEB |
| May 17, 2002 | K021274 | PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719 Baxter Healthcare Corp | MEB |
| Apr 4, 2002 | K020988 | PAIN CARE 4200 Breg, Inc. | MEB |
| Mar 26, 2002 | K020862 | I-FLOW ELASTOMERIC PUMP I-Flow Corp. | MEB |
| Mar 20, 2002 | K020660 | HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO I-Flow Corp. | MEB |
| Dec 3, 2001 | K013928 | PAIN CARE 3200 Breg, Inc. | MEB |
| Jul 9, 2001 | K011117 | MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS Mps Acacia | MEB |
| Jun 28, 2001 | K011317 | MULTIRATE INFUSOR SV; MULTIRATE INFUSER LV; BAXTER PAIN MATE PAIN MANAGEMENT SYSTEM Baxter Healthcare Corp | MEB |
| Jun 5, 2001 | K010824 | PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT Science Incorporated | MEB |
| Feb 15, 2001 | K003915 | ACCUFUSER; ACCUFUSER PLUS Help Technologies | MEB |
| Jan 12, 2001 | K003476 | MPS ACACIA PAIN KIT Mps Acacia | MEB |
| Sep 19, 2000 | K002073 | PAIN CARE 3000 Breg, Inc. | MEB |
| Sep 7, 2000 | K001342 | P.O.P. PAIN KIT Post Operative Pain Management | MEB |
| Aug 14, 2000 | K002321 | PAIN CARE 2000L Breg, Inc. | MEB |
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