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) → LZG — Pump, Infusion, Insulin # LZG · Pump, Infusion, Insulin _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/LZG ## Overview - **Product Code:** LZG - **Device Name:** Pump, Infusion, Insulin - **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 84) Showing 20 most recent of 84 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253534](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG/K253534.md) | Pivot Insulin Delivery System | Modular Medical | Apr 8, 2026 | SESE | | [K240158](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG/K240158.md) | Modular Medical MODD1 Insulin Delivery System | Modular Medical, Inc. | Sep 4, 2024 | SESE | | [K241622](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG/K241622.md) | Extended Reservoir; MiniMed Reservoir | Medtronic Minimed | Jul 2, 2024 | SESE | | [K223372](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG/K223372.md) | Omnipod GO Insulin Delivery Device | Insulet Corporation | Apr 24, 2023 | SESE | | [K210714](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG/K210714.md) | Extended Reservoir | Medtronic Minimed, Inc. | Apr 6, 2022 | SESE | | [K211575](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG/K211575.md) | Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System | Insulet Corporation | Aug 13, 2021 | SESE | | [K192659](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG/K192659.md) | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | Insulet Corporation | Oct 21, 2019 | SESE | | [K182630](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG/K182630.md) | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | Insulet Corporation | Jan 8, 2019 | SESE | | [K180045](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG/K180045.md) | Omnipod DASH Insulin Management System | Insulet Corporation | Jun 1, 2018 | SESE | | [K162296](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG/K162296.md) | OmniPod Insulin Management System | Insulet Corporation | Apr 18, 2017 | SESE | | [K162080](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG/K162080.md) | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater | Tandem Diabetes Care, Inc. | Oct 25, 2016 | SESE | | [K160056](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG/K160056.md) | t:slim Insulin Delivery System | Tandem Diabetes Care, Inc. | Jul 25, 2016 | SESE | | [K160482](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG/K160482.md) | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater | Tandem Diabetes Care, Inc. | Jul 13, 2016 | SESE | | [K160252](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG/K160252.md) | OmniPod Insulin Management System | Insulet Corporation | Apr 27, 2016 | SESE | | [K143189](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG/K143189.md) | t:flex Insulin Delivery System | Tandem Diabetes Care, Inc. | Jan 9, 2015 | SESE | | [K142619](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG/K142619.md) | Snap Insulin Pump System | Asante Solutions, Inc. | Dec 18, 2014 | SESE | | [K140439](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG/K140439.md) | OMNIPOD INSULIN MANAGEMENT SYSTEM | Insulet Corporation | Nov 13, 2014 | SESE | | [K141758](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG/K141758.md) | T:SLIM INSULIN DELIVERY SYSTEM | Tandem Diabetes Care, Inc. | Oct 31, 2014 | SESE | | [K133593](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG/K133593.md) | T:SLIM INSULIN DELIVERY SYSTEM | Tandem Diabetes Care, Inc. | Mar 24, 2014 | SESE | | [K131294](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG/K131294.md) | OMNIPOD INSULIN MANAGEMENT SYSTEM | Insulet Corporation | Aug 29, 2013 | SESE | ## Top Applicants - Medtronic Minimed — 14 clearances - Insulet Corporation — 12 clearances - Animas Corp. — 7 clearances - Tandem Diabetes Care, Inc. — 7 clearances - Disetronic Medical Systems AG — 6 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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