← Product Code [FRN](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN) · K955231 # MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP (K955231) _Medex, Inc. · FRN · Jul 18, 1996 · General Hospital · ST_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K955231 ## Device Facts - **Applicant:** Medex, Inc. - **Product Code:** [FRN](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN.md) - **Decision Date:** Jul 18, 1996 - **Decision:** ST - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5725 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use The intended medical application of Medex Medfusion 2000 Series syringe pumps is to produce controlled movement of the plunger of a syringe to inject a set amount of therapeutic fluid into a patient within a hospital setting at a set rate and at set times. ## Device Story Medfusion 2001, 2010, & 2010i syringe pumps; hospital-use infusion devices. Function: controlled plunger movement for precise therapeutic fluid delivery. Modification: replacement of microprocessor/memory chip with drop-in microprocessor-EPROM daughter board; associated software memory address updates. Operation: identical to predicate models. Output: controlled fluid infusion. Benefit: consistent, timed medication delivery. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Syringe pump; plastic exterior; no fluid/drug contacting surfaces. Energy source: same as predicate. Microprocessor/EPROM daughter board hardware. Software: modified memory addresses to accommodate hardware change. ## Regulatory 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. ## Predicate Devices - Medex Medfusion 2001 (previous model) - Medex Medfusion 2010 (previous model) - Medex Medfusion 2010i (previous model) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [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/). {0} K955231 medexinc JUL 18 1996 # 510(k) SUMMARY FOR MEDEX MEDFUSION 2001, 2010, & 2010i WITH NEW MICROPROCESSOR/MEMORY SYSTEM The following summary of safety and effectiveness information is provided as required by Section 807.92(c) of the Safe Medical Devices Act of 1990. | Submitter | Medex, Inc. | | --- | --- | | Contact person | James W. Lewis | | Summary prepared | 22 April 1996 | | Trade names | Medfusion 2001, 2010, & 2010i | | Common name | Syringe pump | | Classification name | Infusion pump (per 21 CFR 880.5725) | | Predicate devices | The legally marketed devices to which these new devices are equivalent are the previous products marketed by Medex under the same trade names | | Device description | The new model Medex Medfusion Series 2000 pumps are identical to their predicate models with the exception that the microprocessor/memory chip is replaced by a drop-in replacement microprocessor–EPROM daughter board and that associated memory addresses in the software are modified to accommodate the hardware change. The exterior surfaces are made of plastics. There are no fluid or drug contacting surfaces. | | Intended use | The intended medical application of Medex Medfusion 2000 Series syringe pumps is to produce controlled movement of the plunger of a syringe to inject a set amount of therapeutic fluid into a patient within a hospital setting at a set rate and at set times. | | Technological characteristics | The basic design, material, chemical composition, and energy sources are the same as for the current corresponding Medex Medfusion model pumps. They are identical in operation, function, features, and form as their predicate devices and represent no technological differences. | 11360 Technology Circle • Duluth, GA 30155 USA • (770) 623-9809 • FAX: (770) 497-0736 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K955231](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K955231) **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. 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