FDA.reportPublic FDA data

510(k) K251980

Device
ClaveQS™ Bag
Applicant
Icu Medical, Inc.
510(k) number
K251980
Product code
KPE
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-20
Date received
2025-06-27
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
Summary
Third party reviewed
N

Applicant Contact#

Contact
Jeffrey Wan
Address
951 Calle Amanecer San Clemente CA US 92673 92673

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
K121161EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINERActa Medical, LLC2012-07-13