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) → LZH — Pump, Infusion, Enteral # LZH · Pump, Infusion, Enteral _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/LZH ## Overview - **Product Code:** LZH - **Device Name:** Pump, Infusion, Enteral - **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 34) Showing 20 most recent of 34 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253558](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH/K253558.md) | Luminoah FLOW™ Enteral Nutrition System | Luminoah | Apr 20, 2026 | SESE | | [K232205](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH/K232205.md) | Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco Q™ 40mm Screw Cap Feed Set; Vesco Q™ ENPlus Feed Set | Vesco Medical, LLC | Oct 23, 2023 | SESE | | [K221603](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH/K221603.md) | Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD );Kangaroo OMNI™ ENtelliSet 500ml (E5FD );Kangaroo OMNI™ Feeding Set 1000ml (B10FD );Kangaroo OMNI™ ENtelliSet 1000ml (E10FD );Kangaroo OMNI™ ENPlus Spike Set (BSPFD );Kangaroo OMNI™ ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI™ Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI™ ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI™ Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI™ | Cardinal Health, LLC | Dec 20, 2022 | SESE | | [K220230](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH/K220230.md) | AMSure Enteral Feeding Pump | Amsino International, Inc. | Nov 10, 2022 | SESE | | [K200051](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH/K200051.md) | PUGGLE Enteral Feeding Pump and Feeding Set | Amsino International, Inc. | Sep 25, 2020 | SESE | | [K153074](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH/K153074.md) | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal | Covidien | Jul 6, 2016 | SESE | | [K143263](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH/K143263.md) | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets | Covidien | May 29, 2015 | SESE | | [K141479](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH/K141479.md) | KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS | Covidien | Dec 23, 2014 | SESE | | [K131154](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH/K131154.md) | ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET; | Zevex, Inc. | Feb 12, 2014 | SESE | | [K111381](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH/K111381.md) | MEDI-SIS SYRINGE INFUSION SYSTEM | Acacia, Inc. | Jan 13, 2012 | SESE | | [K060316](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH/K060316.md) | COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS | Fresenius Kabi Deutschland GmbH | Jun 23, 2006 | SESE | | [K040957](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH/K040957.md) | NOA III ENTERAL NUTRITION PUMP | Caesarea Medical Electronics , Ltd. | May 21, 2004 | SESE | | [K040196](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH/K040196.md) | KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS | Tyco Healthcare/Kendall | May 5, 2004 | SESE | | [K031199](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH/K031199.md) | ENTERALITE INFINITY ENTERAL FEEDING PUMP | Zevex Intl., Inc. | Jul 9, 2003 | SESE | | [K031407](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH/K031407.md) | ROSS EMBRACE ENTERAL PUMP | Ross Product Div. Abbott Laboratories | May 20, 2003 | SESE | | [K011868](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH/K011868.md) | ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS | Debio Tech SA | Sep 4, 2001 | SESE | | [K003047](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH/K003047.md) | AMBULATORY ENTERAL NUTRITION PUMP | Ross Product Div. Abbott Laboratories | Jun 12, 2001 | SESE | | [K011587](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH/K011587.md) | SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP | Entracon Corp. | Jun 1, 2001 | SESE | | [K981541](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH/K981541.md) | CLEARSTAR ENTERAL NUTRITION PUMP | Frantz Medical Development, Ltd. | Aug 13, 1998 | SESE | | [K954735](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH/K954735.md) | ENTERALITE | Zevex Intl., Inc. | Apr 15, 1996 | ST | ## Top Applicants - Covidien — 3 clearances - Sandoz Nutrition — 3 clearances - Amsino International, Inc. — 2 clearances - Frantz Medical Development, Ltd. — 2 clearances - Ross Product Div. Abbott Laboratories — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH) **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