MEB · Pump, Infusion, Elastomeric
General Hospital · 21 CFR 880.5725 · Class 2
Overview
| Product Code | MEB |
|---|---|
| Device Name | Pump, Infusion, Elastomeric |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 88)
Showing 20 most recent of 88 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250234 | SMARTeZ Elastomeric Infusion Pump (RS series) | Epic Medical Pte. , Ltd. | Apr 24, 2026 | SESE |
| K240624 | InfuLife | First Medical Source, LLC | Nov 5, 2024 | SESE |
| K242152 | SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) | Epic Medical Pte. , Ltd. | Oct 7, 2024 | SESE |
| K181360 | ON-Q* Pump with Bolus | Halyard Health | Mar 22, 2019 | SESE |
| K151650 | SMARTez elastomeric infusion pump | Epic Medical Pte. , Ltd. | Apr 4, 2016 | SESE |
| K131249 | ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES | I-Flow, LLC | Feb 3, 2014 | SESE |
| K131247 | MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM | Mfs - Medical Flow Systems, Ltd. | Aug 14, 2013 | SESE |
| K090300 | MODIFICATION TO AUTOFUSER | Ace Medical Us, LLC | Apr 30, 2009 | SESE |
| K081905 | ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP | Westmed, Inc. | Jul 15, 2008 | SESE |
| K071532 | ALPHA INFUSION PUMP, MODEL A200, A450 | Advanced Infusion, Inc. | Feb 19, 2008 | SESE |
| K072921 | DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM | Symbios Medical Products, LLC | Nov 26, 2007 | SESE |
| K072053 | SMARTBLOCK PAIN PUMP | Medical Flow Systems, Ltd. | Nov 6, 2007 | SESE |
| K071735 | MODIFICATION TO DISPOSABLE INFUSION PUMP KIT | Symbios Medical Products, LLC | Jul 19, 2007 | SESE |
| K071222 | INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES | Baxter Healthcare Corp | May 25, 2007 | SESE |
| K063530 | ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP | I-Flow Corp. | Jan 26, 2007 | SESE |
| K061661 | STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20 | Advanced Infusion, Inc. | Oct 18, 2006 | SESE |
| K062457 | INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES | Baxter Healthcare Corporation | Sep 21, 2006 | SESE |
| K061409 | SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET | Precise Medical Products, Ltd. | Jun 16, 2006 | SESE |
| K060258 | AUTOFUSER | Ace Medical Us, LLC | May 30, 2006 | SESE |
| K060933 | SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM | Apex Medical Technologies, Inc. | May 9, 2006 | SESE |
Top Applicants
- I-Flow Corp. — 16 clearances
- Baxter Healthcare Corp — 7 clearances
- Novacon Corp. — 6 clearances
- Advanced Infusion, Inc. — 5 clearances
- Breg, Inc. — 5 clearances
