LZH · Pump, Infusion, Enteral
General Hospital · 21 CFR 880.5725 · Class 2
Overview
| Product Code | LZH |
|---|---|
| Device Name | Pump, Infusion, Enteral |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
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 | Luminoah FLOW Enteral Nutrition System | Luminoah | Apr 20, 2026 | SESE |
| K232205 | 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 | 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 | AMSure Enteral Feeding Pump | Amsino International, Inc. | Nov 10, 2022 | SESE |
| K200051 | PUGGLE Enteral Feeding Pump and Feeding Set | Amsino International, Inc. | Sep 25, 2020 | SESE |
| K153074 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal | Covidien | Jul 6, 2016 | SESE |
| K143263 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets | Covidien | May 29, 2015 | SESE |
| K141479 | KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS | Covidien | Dec 23, 2014 | SESE |
| K131154 | ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET; | Zevex, Inc. | Feb 12, 2014 | SESE |
| K111381 | MEDI-SIS SYRINGE INFUSION SYSTEM | Acacia, Inc. | Jan 13, 2012 | SESE |
| K060316 | COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS | Fresenius Kabi Deutschland GmbH | Jun 23, 2006 | SESE |
| K040957 | NOA III ENTERAL NUTRITION PUMP | Caesarea Medical Electronics , Ltd. | May 21, 2004 | SESE |
| K040196 | KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS | Tyco Healthcare/Kendall | May 5, 2004 | SESE |
| K031199 | ENTERALITE INFINITY ENTERAL FEEDING PUMP | Zevex Intl., Inc. | Jul 9, 2003 | SESE |
| K031407 | ROSS EMBRACE ENTERAL PUMP | Ross Product Div. Abbott Laboratories | May 20, 2003 | SESE |
| K011868 | ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS | Debio Tech SA | Sep 4, 2001 | SESE |
| K003047 | AMBULATORY ENTERAL NUTRITION PUMP | Ross Product Div. Abbott Laboratories | Jun 12, 2001 | SESE |
| K011587 | SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP | Entracon Corp. | Jun 1, 2001 | SESE |
| K981541 | CLEARSTAR ENTERAL NUTRITION PUMP | Frantz Medical Development, Ltd. | Aug 13, 1998 | SESE |
| K954735 | 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
