Product code MEB
- Device name
- Pump, Infusion, Elastomeric
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5725
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250234 | SMARTeZ™ Elastomeric Infusion Pump (RS series) | Epic Medical Pte. , Ltd. | 2026-04-24 |
| K240624 | InfuLife | First Medical Source, LLC | 2024-11-05 |
| K242152 | SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) | Epic Medical Pte. , Ltd. | 2024-10-07 |
| K181360 | ON-Q* Pump with Bolus | Halyard Health | 2019-03-22 |
| K151650 | SMARTez elastomeric infusion pump | Epic Medical Pte. , Ltd. | 2016-04-04 |
| K131249 | ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES | I-Flow, LLC | 2014-02-03 |
| K131247 | MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM | Mfs - Medical Flow Systems, Ltd. | 2013-08-14 |
| K090300 | MODIFICATION TO AUTOFUSER | Ace Medical Us, LLC | 2009-04-30 |
| K081905 | ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP | Westmed, Inc. | 2008-07-15 |
| K071532 | ALPHA INFUSION PUMP, MODEL A200, A450 | Advanced Infusion, Inc. | 2008-02-19 |
| K072921 | DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM | Symbios Medical Products, LLC | 2007-11-26 |
| K072053 | SMARTBLOCK PAIN PUMP | Medical Flow Systems, Ltd. | 2007-11-06 |
| K071735 | MODIFICATION TO DISPOSABLE INFUSION PUMP KIT | Symbios Medical Products, LLC | 2007-07-19 |
| K071222 | INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES | Baxter Healthcare Corp | 2007-05-25 |
| K063530 | ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP | I-Flow Corp. | 2007-01-26 |
| K061661 | STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20 | Advanced Infusion, Inc. | 2006-10-18 |
| K062457 | INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES | Baxter Healthcare Corporation | 2006-09-21 |
| K061409 | SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET | Precise Medical Products, Ltd. | 2006-06-16 |
| K060258 | AUTOFUSER | Ace Medical Us, LLC | 2006-05-30 |
| K060933 | SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM | Apex Medical Technologies, Inc. | 2006-05-09 |
| K052999 | SEMPERFLO INFUSION SYSTEM | ETHICON, Inc. | 2006-03-22 |
| K051828 | NIPRO SUREFUSER AMBULATORY INFUSION PUMP | Nipro Medical Corporation | 2005-12-15 |
| K052451 | MPS ACACIA MEDFLO ELASTOMERIC PUMP | Mps Acacia | 2005-12-08 |
| K052117 | I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) | I-Flow Corp. | 2005-09-09 |
| K051474 | SYMBIOS DISPOSABLE INFUSION PUMP KIT | Symbios Medical Products, LLC | 2005-07-01 |
| K050770 | MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT | Mckinley Medical, LLC | 2005-04-14 |
| K042122 | SMARTINFUSER PAINPUMP | Precise Medical Products | 2004-09-22 |
| K042246 | MULTI-DRIP INFUSION CATHETER | Advanced Infusion, Inc. | 2004-08-31 |
| K041585 | AUTOFUSER AMBULATORY INFUSION PUMP | Algos, LC | 2004-08-26 |
| K040337 | I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP) | I-Flow Corp. | 2004-05-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 18859299175178 | SMARTeZ RS | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2026-09-04 |
| 18859299175185 | SMARTeZ RS | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2026-09-04 |
| 18859299175192 | SMARTeZ RS | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2026-09-04 |
| 18859299175079 | SMARTeZ RS | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2026-09-04 |
| 08436020761898 | DOSI-FUSER | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2017-09-12 |
| 08436020762031 | DOSI-FUSER | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2017-08-30 |
| 08436020762109 | DOSI-FUSER | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2017-05-02 |
| 08436020760051 | DOSI-FUSER | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2017-04-26 |
| 08436020764196 | DOSI-FUSER | LEVENTON SAU | 2016-08-31 |
| 08436020766077 | DOSI-FUSER | LEVENTON SAU | 2016-08-31 |
| 08436020764202 | DOSI-FUSER | LEVENTON SAU | 2016-08-31 |
| 08436020764219 | DOSI-FUSER | LEVENTON SAU | 2016-08-31 |
| 08436020764264 | DOSI-FUSER | LEVENTON SAU | 2016-08-31 |
| 08436020764868 | DOSI-FUSER | LEVENTON SAU | 2016-08-31 |
| 08436020764875 | DOSI-FUSER | LEVENTON SAU | 2016-08-31 |
| 08436020764882 | DOSI-FUSER | LEVENTON SAU | 2016-08-31 |
| 08436020764899 | DOSI-FUSER | LEVENTON SAU | 2016-08-31 |
| 08436020764905 | DOSI-FUSER | LEVENTON SAU | 2016-08-31 |
| 08436020763991 | DOSI-FUSER | LEVENTON SAU | 2016-08-31 |
| 08436020763984 | DOSI-FUSER | LEVENTON SAU | 2016-08-31 |
| 08436020763977 | DOSI-FUSER | LEVENTON SAU | 2016-08-31 |
| 08436020763960 | DOSI-FUSER | LEVENTON SAU | 2016-08-31 |
| 08436020763885 | DOSI-FUSER | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2016-08-24 |
| 08436020764851 | DOSI-FUSER | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2016-08-24 |
| 08436020762178 | DOSI-FUSER | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2016-08-24 |
| 08436020761867 | DOSI-FUSER | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2016-08-24 |
| 08436020760082 | DOSI-FUSER | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2016-08-24 |
| 08436020760068 | DOSI-FUSER | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2016-08-24 |
| 08436020760020 | DOSI-FUSER | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2016-08-24 |
| 08436020760013 | DOSI-FUSER | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2016-08-24 |