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) → MRZ — Accessories, Pump, Infusion # MRZ · Accessories, Pump, Infusion _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/MRZ ## Overview - **Product Code:** MRZ - **Device Name:** Accessories, Pump, Infusion - **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 48) Showing 20 most recent of 48 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K230718](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRZ/K230718.md) | UTC 3mL Medication Cartridge | Gilero, LLC | Jun 15, 2023 | SESE | | [K220695](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRZ/K220695.md) | Elite Biomedical Solutions Dose Request Cord | Elite Biomedical Solutions | Apr 29, 2022 | SESE | | [K201634](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRZ/K201634.md) | RG 3ml Medication Cartridge | Chengdu Shifeng Medical Technology Co., Ltd. | Mar 26, 2021 | SESE | | [K193654](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRZ/K193654.md) | BlueStar Rx | Welldoc, Inc. | Apr 7, 2020 | SESE | | [K191910](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRZ/K191910.md) | SpaceStation MRI | B. Braun Melsugen AG | Mar 12, 2020 | SESE | | [K190013](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRZ/K190013.md) | WellDoc BlueStar | Welldoc, Inc. | Nov 4, 2019 | SESE | | [K173531](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRZ/K173531.md) | Lockbox for Perfusor Space PCA Infusion Pump | B.Braun Medical, Inc. | Aug 2, 2018 | SESE | | [K171346](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRZ/K171346.md) | Sapphire Sets | Icu Medical | Aug 25, 2017 | SESE | | [K162532](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRZ/K162532.md) | WellDoc BlueStar, WellDoc BlueStar Rx | Welldoc, Inc. | Jan 12, 2017 | SESE | | [K160492](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRZ/K160492.md) | Hospira Sapphire Sets | Hospira, Inc. | Dec 6, 2016 | SESE | | [K162225](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRZ/K162225.md) | WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System | Welldoc, Inc. | Nov 22, 2016 | SESE | | [K142374](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRZ/K142374.md) | ivWatch Model 400 | Ivwatch, LLC | Feb 13, 2015 | SESE | | [K142333](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRZ/K142333.md) | SMART LABEL, PROPOFOL | American I.V. Products, Inc. Dba Aiv, Inc. | Dec 18, 2014 | SESE | | [K141273](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRZ/K141273.md) | WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE | Welldoc, Inc. | Jul 8, 2014 | SESE | | [K132618](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRZ/K132618.md) | ONETOUCH REVEAL | Lifescan, Inc. | Dec 16, 2013 | SESE | | [K120209](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRZ/K120209.md) | PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE | American I.V. Products, Inc. | Apr 12, 2012 | SESE | | [K120314](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRZ/K120314.md) | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM | Welldoc, Inc. | Feb 24, 2012 | SESE | | [K112370](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRZ/K112370.md) | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM | Welldoc, Inc. | Oct 14, 2011 | SESE | | [K101806](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRZ/K101806.md) | AIDERA DIASEND SYSTEM | Aidera AB | Dec 7, 2010 | SESE | | [K100066](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRZ/K100066.md) | DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 | Welldoc, Inc. | Jul 15, 2010 | SESE | ## Top Applicants - Alexander Mfg. Co. — 8 clearances - Welldoc, Inc. — 8 clearances - National Custom Ent., Inc. — 3 clearances - Smiths Medical MD, Inc. — 3 clearances - Aidera AB — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRZ](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRZ) **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