Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

70 results for "Icu Medical, Inc."
1–24 of 70
Search insights Median review: 111d Cleared: 100% Top manufacturer: Icu Medical, Inc. Lead specialty: General Hospital
Cleared Apr 02, 2026
LifeShield Infusion Safety Software Suite
K252130 · PHC
Icu Medical, Inc.
General Hospital · 269d
Cleared Mar 27, 2026
OTTO™ Disinfecting Cap
K252006 · QBP
Icu Medical, Inc.
General Hospital · 273d
Cleared Mar 20, 2026
ClaveQS™ Bag
K251980 · KPE
Icu Medical, Inc.
General Hospital · 266d
Cleared Jun 05, 2025
Clave™ Neutral-Displacement Needlefree Connectors
K250616 · FPA
Icu Medical, Inc.
General Hospital · 97d
Cleared Apr 02, 2025
LifeShield Infusion Safety Software Suite
K242117 · PHC
Icu Medical, Inc.
General Hospital · 257d
Cleared Apr 02, 2025
Plum Duo™ Precision IV Pump
K242115 · FRN
Icu Medical, Inc.
General Hospital · 257d
Cleared Apr 02, 2025
Plum Solo™ Precision IV Pump
K242114 · FRN
Icu Medical, Inc.
General Hospital · 257d
Cleared Jan 22, 2025
Rio™ Drug Reconstitution Transfer Device
K243985 · LHI
Icu Medical, Inc.
General Hospital · 30d
Cleared Aug 24, 2023
Plum Duo™ Infusion System
K223607 · FRN
Icu Medical, Inc.
General Hospital · 265d
Cleared Aug 24, 2023
LifeShield™ Infusion Safety Software Suite
K223606 · PHC
Icu Medical, Inc.
General Hospital · 265d
Cleared Aug 31, 2018
ChemoCLAVE Cytotoxic Medication Preparation and Delivery System
K173477 · ONB
Icu Medical, Inc.
General Hospital · 291d
Cleared Aug 10, 2018
Diana Medication Transfer Set
K170110 · ONB
Icu Medical, Inc.
General Hospital · 575d
Cleared May 05, 2016
Cogent Hemodynamic Monitoring System
K152006 · DXQ
Icu Medical, Inc.
Cardiovascular · 289d
Cleared Jan 19, 2016
Hospira Extension Sets
K151969 · FPA
Icu Medical, Inc.
General Hospital · 187d
Cleared Mar 04, 2015
Hospira Blood Set
K143087 · FPA
Hospira, Inc.
General Hospital · 128d
Cleared Jan 16, 2015
PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0...
K141789 · FRN
Hospira, Inc.
General Hospital · 198d
Cleared Jan 15, 2015
IV Administration
K142622 · FPA
Hospira, Inc.
General Hospital · 121d
Cleared Nov 25, 2014
Hospira Primary Sets
K142367 · FPA
Hospira, Inc.
General Hospital · 92d
Cleared Jul 02, 2014
PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY...
K140129 · DQE
Icu Medical, Inc.
Cardiovascular · 167d
Cleared Jul 26, 2013
CHEMOLOCK, CHEMOLOCK PORT
K131549 · ONB
Icu Medical, Inc.
General Hospital · 58d
Cleared Dec 17, 2010
HIGH PRESSURE SETS-400 PSI
K100576 · FPA
Icu Medical, Inc.
General Hospital · 291d
Cleared Jul 09, 2010
CLAVE NEUTRON
K100434 · FPA
Icu Medical, Inc.
General Hospital · 143d
Cleared Apr 10, 2009
ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE
K090189 · FPA
Icu Medical, Inc.
General Hospital · 74d
Cleared Apr 06, 2009
SPINNING SPIROS, MODEL CH-2000
K082806 · FPA
Icu Medical, Inc.
General Hospital · 194d