LZH — Pump, Infusion, Enteral Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K232205vesco medicalVesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag October 23, 2023
K221603cardinal healthKangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml December 20, 2022
K220230amsino internationalAMSure Enteral Feeding PumpNovember 10, 2022
K200051amsino internationalPUGGLE Enteral Feeding Pump and Feeding SetSeptember 25, 2020
K153074covidienKangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, KangarJuly 6, 2016
K143263covidienKangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding SetsMay 29, 2015
K141479covidienKANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORSDecember 23, 2014
K131154zevexENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG EFebruary 12, 2014
K111381acaciaMEDI-SIS SYRINGE INFUSION SYSTEMJanuary 13, 2012
K060316fresenius kabi deutschlandCOMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETSJune 23, 2006
K040957caesarea medical electronicsNOA III ENTERAL NUTRITION PUMPMay 21, 2004
K040196tyco healthcare/kendallKENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETSMay 5, 2004
K031199zevex intlENTERALITE INFINITY ENTERAL FEEDING PUMPJuly 9, 2003
K031407ross product div. abbott laboratoriesROSS EMBRACE ENTERAL PUMPMay 20, 2003
K011868debio techENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETSSeptember 4, 2001
K003047ross product div. abbott laboratoriesAMBULATORY ENTERAL NUTRITION PUMPJune 12, 2001
K011587entraconSENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMPJune 1, 2001
K981541frantz medical developmentCLEARSTAR ENTERAL NUTRITION PUMPAugust 13, 1998
K954735zevex intlENTERALITEApril 15, 1996
K946168ivac corporationIVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPSMarch 21, 1996