FDA.reportPublic FDA data

510(k) K252006

Device
OTTO™ Disinfecting Cap
Applicant
Icu Medical, Inc.
510(k) number
K252006
Product code
QBP
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-27
Date received
2025-06-27
Regulation
880.5440
Classification name
Cap, Device Disinfectant
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
Nichelle Cato
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 QBP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251592SteriHub™ Disinfecting Device and Protective Cover1World Vista Medical2026-02-11
K223914ACTIV™ CapCleansite Medical, Inc.2024-04-05
K193190BD PureHub Disinfecting CapBecton, Dickinson and Company2020-11-09
K200299Curos Jet Disinfecting Cap3M Company2020-10-29
K192382CapKlenZStar Mountain Medical, Inc.2020-04-20
K190918SwabTip Male Disinfectant CapIcu Medical2020-03-06
K142806DualCapCatheter Connections, Inc.2015-05-22
K140657CUROS RED PORT PROTECTORIvera Medical, Inc.2014-12-04
K142399DualCap IV Pole Strips(Disinfectant Caps for Male Luers)Catheter Connections, Inc.2014-11-19
K130975SWABCAP AND SWABFLUSHExcelsior Medical Corp.2013-12-24
K123967CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERSCatheter Connections, Inc.2013-01-22
K123065CATHETER CONNECTIONS DUALCAP SOLOCatheter Connections, Inc.2012-12-14
K121171CUROS TIPIvera Medical, Inc.2012-11-26
K113842CATHETER CONNECTIONS' DUALCAP SOLOCatheter Connections, Inc.2012-01-27
K111992CUROS PORT PROTECTORIvera Medical, Inc.2012-01-12