FDA.reportPublic FDA data

510(k) K232205

Device
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
Applicant
Vesco Medical, LLC
510(k) number
K232205
Product code
LZH
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-23
Date received
2023-07-25
Regulation
880.5725
Classification name
Pump, Infusion, Enteral
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Chris O'Keefe
Address
60 Collegeview Rd., Suite 144 Westerville OH US 43081 43081

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LZH#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253558Luminoah FLOW™ Enteral Nutrition SystemLuminoah2026-04-20
K221603Kangaroo 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, LLC2022-12-20
K220230AMSure Enteral Feeding PumpAmsino International, Inc.2022-11-10
K200051PUGGLE Enteral Feeding Pump and Feeding SetAmsino International, Inc.2020-09-25
K153074Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect PortalCovidien2016-07-06
K143263Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding SetsCovidien2015-05-29
K141479KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORSCovidien2014-12-23
K131154ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET;Zevex, Inc.2014-02-12
K111381MEDI-SIS SYRINGE INFUSION SYSTEMAcacia, Inc.2012-01-13
K060316COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETSFresenius Kabi Deutschland GmbH2006-06-23
K040957NOA III ENTERAL NUTRITION PUMPCaesarea Medical Electronics , Ltd.2004-05-21
K040196KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETSTyco Healthcare/Kendall2004-05-05
K031199ENTERALITE INFINITY ENTERAL FEEDING PUMPZevex Intl., Inc.2003-07-09
K031407ROSS EMBRACE ENTERAL PUMPRoss Product Div. Abbott Laboratories2003-05-20
K011868ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETSDebio Tech SA2001-09-04