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) → MEA — Pump, Infusion, Pca # MEA · Pump, Infusion, Pca _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/MEA ## Overview - **Product Code:** MEA - **Device Name:** Pump, Infusion, Pca - **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 31) Showing 20 most recent of 31 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K162165](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEA/K162165.md) | ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump | Summit Medical Products, Inc. | Aug 29, 2017 | SESE | | [K170982](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEA/K170982.md) | CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) | Smiths Medical Ads, Inc. | Aug 24, 2017 | SESE | | [K143612](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEA/K143612.md) | LifeCare PCA Infusion System | Hospira, Inc. | Apr 8, 2016 | SESE | | [K130394](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEA/K130394.md) | CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 | Smiths Medical Asd, Inc. | Dec 9, 2013 | SESE | | [K092313](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEA/K092313.md) | PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM | B.Braun Medical, Inc. | Nov 4, 2009 | SESE | | [K072144](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEA/K072144.md) | CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR | Smiths Medical MD, Inc. | Mar 7, 2008 | SESE | | [K051253](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEA/K051253.md) | MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM) | Baxter Healthcare Corp | Jul 15, 2005 | SESE | | [K043299](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEA/K043299.md) | MEDLEY PCA MODULE, MODEL 8120 | Alaris Medical Systems, Inc. | Dec 10, 2004 | SESE | | [K043256](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEA/K043256.md) | HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 | Hospira, Inc. | Dec 6, 2004 | SESE | | [K042800](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEA/K042800.md) | LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE | Hospira, Inc. | Oct 18, 2004 | SESE | | [K033054](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEA/K033054.md) | HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP | Harvard Clinical Technology | Dec 16, 2003 | SESE | | [K032233](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEA/K032233.md) | MEDLEY PCA MODULE, MODEL 8120 | Alaris Medical Systems, Inc. | Sep 9, 2003 | SESE | | [K031566](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEA/K031566.md) | SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 | Baxter Healthcare Corp | Aug 19, 2003 | SESE | | [K030661](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEA/K030661.md) | STRYKER PAINPUMP2 | Stryker Instruments | May 30, 2003 | SESE | | [K020421](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEA/K020421.md) | GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES | Hennig Enterprises Europe Srl | Apr 29, 2003 | SESE | | [K020418](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEA/K020418.md) | GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES | P.T. Greenleaf | Apr 29, 2003 | SESE | | [K022203](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEA/K022203.md) | ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384 | Abbott Laboratories | Aug 1, 2002 | SESE | | [K013822](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEA/K013822.md) | MICROJET CRONO PCA | Cane S.R.L. | May 8, 2002 | SESE | | [K002739](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEA/K002739.md) | INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K | Baxter Healthcare Corp | Sep 11, 2000 | SESE | | [K002434](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEA/K002434.md) | PALM PUMP | Sorenson Medical, Inc. | Aug 23, 2000 | SESE | ## Top Applicants - Baxter Healthcare Corp — 3 clearances - Hospira, Inc. — 3 clearances - Alaris Medical Systems, Inc. — 2 clearances - C.R. Bard, Inc. — 2 clearances - Pharmacia Deltec, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEA](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MEA) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com