LZH — Pump, Infusion, Enteral Class II
FDA product code LZH covers "Pump, Infusion, Enteral", a Class II medical device regulated under 21 CFR 880.5725. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LZH
- Device Class
- Class II
- Regulation Number
- 880.5725
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253558 | luminoah | Luminoah FLOW Enteral Nutrition System | April 20, 2026 |
| K232205 | vesco medical | Vesco Q Enteral Feeding Pump; Vesco Q 500mL Bag Feed Set; Vesco Q 1000mL Bag | October 23, 2023 |
| K221603 | cardinal health | Kangaroo OMNI Enteral Feeding Pump (385400 );Kangaroo OMNI Feeding Set 500ml | December 20, 2022 |
| K220230 | amsino international | AMSure Enteral Feeding Pump | November 10, 2022 |
| K200051 | amsino international | PUGGLE Enteral Feeding Pump and Feeding Set | September 25, 2020 |
| K153074 | covidien | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangar | July 6, 2016 |
| K143263 | covidien | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets | May 29, 2015 |
| K141479 | covidien | KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS | December 23, 2014 |
| K131154 | zevex | ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG E | February 12, 2014 |
| K111381 | acacia | MEDI-SIS SYRINGE INFUSION SYSTEM | January 13, 2012 |
| K060316 | fresenius kabi deutschland | COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS | June 23, 2006 |
| K040957 | caesarea medical electronics | NOA III ENTERAL NUTRITION PUMP | May 21, 2004 |
| K040196 | tyco healthcare/kendall | KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS | May 5, 2004 |
| K031199 | zevex intl | ENTERALITE INFINITY ENTERAL FEEDING PUMP | July 9, 2003 |
| K031407 | ross product div. abbott laboratories | ROSS EMBRACE ENTERAL PUMP | May 20, 2003 |
| K011868 | debio tech | ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS | September 4, 2001 |
| K003047 | ross product div. abbott laboratories | AMBULATORY ENTERAL NUTRITION PUMP | June 12, 2001 |
| K011587 | entracon | SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP | June 1, 2001 |
| K981541 | frantz medical development | CLEARSTAR ENTERAL NUTRITION PUMP | August 13, 1998 |
| K954735 | zevex intl | ENTERALITE | April 15, 1996 |