FDA.reportPublic FDA data

510(k) K001287

Device
EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML
Applicant
SORENSON MEDICAL, INC.
510(k) number
K001287
Product code
KPE  
Decision
Substantially Equivalent (SESE)
Decision date
2000-06-09
Date received
2000-04-24
Regulation
880.5025
Classification name
Container, I.v.
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
R. DOUGLAS JACOB
Address
1375 W. 8040 S. West Jordan UT US 84088 84088

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