MEB — Pump, Infusion, Elastomeric Class II
FDA product code MEB covers "Pump, Infusion, Elastomeric", a Class II medical device regulated under 21 CFR 880.5725. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MEB
- Device Class
- Class II
- Regulation Number
- 880.5725
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250234 | epic medical pte. | SMARTeZ Elastomeric Infusion Pump (RS series) | April 24, 2026 |
| K240624 | first medical source | InfuLife | November 5, 2024 |
| K242152 | epic medical pte. | SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) | October 7, 2024 |
| K181360 | halyard health | ON-Q* Pump with Bolus | March 22, 2019 |
| K151650 | epic medical pte. | SMARTez elastomeric infusion pump | April 4, 2016 |
| K131249 | i-flow | ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES | February 3, 2014 |
| K131247 | mfs - medical flow systems | MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM | August 14, 2013 |
| K090300 | ace medical us | MODIFICATION TO AUTOFUSER | April 30, 2009 |
| K081905 | westmed | ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP | July 15, 2008 |
| K071532 | advanced infusion | ALPHA INFUSION PUMP, MODEL A200, A450 | February 19, 2008 |
| K072921 | symbios medical products | DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM | November 26, 2007 |
| K072053 | medical flow systems | SMARTBLOCK PAIN PUMP | November 6, 2007 |
| K071735 | symbios medical products | MODIFICATION TO DISPOSABLE INFUSION PUMP KIT | July 19, 2007 |
| K071222 | baxter healthcare | INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES | May 25, 2007 |
| K063530 | i-flow | ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, | January 26, 2007 |
| K061661 | advanced infusion | STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20 | October 18, 2006 |
| K062457 | baxter healthcare corporation | INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES | September 21, 2006 |
| K061409 | precise medical products | SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET | June 16, 2006 |
| K060258 | ace medical us | AUTOFUSER | May 30, 2006 |
| K060933 | apex medical technologies | SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM | May 9, 2006 |