Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5725](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5725) → MEB — Pump, Infusion, Elastomeric # MEB · Pump, Infusion, Elastomeric _General Hospital · 21 CFR 880.5725 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEB ## Overview - **Product Code:** MEB - **Device Name:** Pump, Infusion, Elastomeric - **Regulation:** [21 CFR 880.5725](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5725) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) ## 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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEB/K250234.md) | SMARTeZ™ Elastomeric Infusion Pump (RS series) | Epic Medical Pte. , Ltd. | Apr 24, 2026 | SESE | | [K240624](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEB/K240624.md) | InfuLife | First Medical Source, LLC | Nov 5, 2024 | SESE | | [K242152](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEB/K242152.md) | SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) | Epic Medical Pte. , Ltd. | Oct 7, 2024 | SESE | | [K181360](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEB/K181360.md) | ON-Q* Pump with Bolus | Halyard Health | Mar 22, 2019 | SESE | | [K151650](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEB/K151650.md) | SMARTez elastomeric infusion pump | Epic Medical Pte. , Ltd. | Apr 4, 2016 | SESE | | [K131249](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEB/K131249.md) | ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES | I-Flow, LLC | Feb 3, 2014 | SESE | | [K131247](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEB/K131247.md) | MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM | Mfs - Medical Flow Systems, Ltd. | Aug 14, 2013 | SESE | | [K090300](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEB/K090300.md) | MODIFICATION TO AUTOFUSER | Ace Medical Us, LLC | Apr 30, 2009 | SESE | | [K081905](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEB/K081905.md) | ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP | Westmed, Inc. | Jul 15, 2008 | SESE | | [K071532](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEB/K071532.md) | ALPHA INFUSION PUMP, MODEL A200, A450 | Advanced Infusion, Inc. | Feb 19, 2008 | SESE | | [K072921](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEB/K072921.md) | DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM | Symbios Medical Products, LLC | Nov 26, 2007 | SESE | | [K072053](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEB/K072053.md) | SMARTBLOCK PAIN PUMP | Medical Flow Systems, Ltd. | Nov 6, 2007 | SESE | | [K071735](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEB/K071735.md) | MODIFICATION TO DISPOSABLE INFUSION PUMP KIT | Symbios Medical Products, LLC | Jul 19, 2007 | SESE | | [K071222](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEB/K071222.md) | INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES | Baxter Healthcare Corp | May 25, 2007 | SESE | | [K063530](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEB/K063530.md) | 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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEB/K061661.md) | STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20 | Advanced Infusion, Inc. | Oct 18, 2006 | SESE | | [K062457](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEB/K062457.md) | INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES | Baxter Healthcare Corporation | Sep 21, 2006 | SESE | | [K061409](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEB/K061409.md) | SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET | Precise Medical Products, Ltd. | Jun 16, 2006 | SESE | | [K060258](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEB/K060258.md) | AUTOFUSER | Ace Medical Us, LLC | May 30, 2006 | SESE | | [K060933](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEB/K060933.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEB](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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