FDA.reportPublic FDA data

510(k) K801652

Device
TOTAL PARENTERAL NUTRITION SET BAG
Applicant
CUTTER LABORATORIES, INC.
510(k) number
K801652
Product code
KPE  
Decision
Substantially Equivalent (SESE)
Decision date
1980-08-27
Date received
1980-07-18
Regulation
880.5025
Classification name
Container, I.v.
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KPE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252079Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd.2026-04-02
K251980ClaveQS™ BagIcu Medical, Inc.2026-03-20
K251139KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AG2026-01-09
K252094eZSURE™ Empty Fluid ContainerEpic Medical Pte. , Ltd.2025-08-01
K250459DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container SolutionTechnoflex Sas.2025-04-18
K241442eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteEpic Medical Pte. , Ltd.2024-06-21
K223674eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)Epic Medical Pte. , Ltd.2023-09-01
K222622Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd.2023-02-16
K210749Empty EVA BagHaemotronic S.P.A.2021-08-19
K201936SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mLGilero, LLC2021-05-06
K193528Empty EVA BagHaemotronic S.P.A.2020-07-22
K190328HCT Empty EVA Container PackHealth Care Technologies2019-08-15
K190305Additive CapInternational Medical Industries, Inc.2019-04-30
K181393Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BPValmed S.R.L.2019-02-15
K132276STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 MLHospira, Inc.2013-11-12

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases