Data / Medical devices / United States / Icu Medical, Inc
Icu Medical, Inc: FDA-registered device maker in Salt Lake City, UT, United States, 48 510(k) clearances
Icu Medical, Inc is registered with the FDA (registration 1713468) in Salt Lake City, UT, United States. It lists 28 device types. The FDA files 48 510(k) clearances under its listings, the newest dated March 6, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1713468
- Address
- 4455 Atherton DR., Salt Lake City, UT, United States, 84123
- Owner or operator
- ICU MEDICAL, INC. (2025816)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- August 1, 1995
- Registered through
- 2026
- Brand names listed
- Accudynamic, Additive Hinge Cap, Advanced Sensor Catheter, Antimicrobial CLAVE, CLAVE Connector, CLAVE Stopcock, CVP CATHETER, CVP Polyurethane Catheter W Heparin (No Balloon) and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 6, 2020 | K190918 | SwabTip Male Disinfectant Cap | QBP | Substantially Equivalent | Icu Medical | accessdata.fda.gov |
| August 10, 2018 | K170110 | Diana Medication Transfer Set | ONB | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| May 25, 2018 | K180111 | ClearGuard HD Antimicrobial Barrier Cap | PEH | Substantially Equivalent | Pursuit Vascular, Inc. | accessdata.fda.gov |
| May 5, 2016 | K152006 | Cogent Hemodynamic Monitoring System | DXQ | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| July 2, 2014 | K140129 | PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER | DQE | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| December 24, 2013 | K130975 | SWABCAP AND SWABFLUSH | QBP | Substantially Equivalent | Excelsior Medical Corp. | accessdata.fda.gov |
| July 26, 2013 | K131549 | CHEMOLOCK, CHEMOLOCK PORT | ONB | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| December 17, 2010 | K100576 | HIGH PRESSURE SETS-400 PSI | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| July 9, 2010 | K100434 | CLAVE NEUTRON | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| September 18, 2009 | K091268 | HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS | DQE | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| April 28, 2009 | K083508 | SWABCAP | QBP | Substantially Equivalent | Excelsior Medical Corp. | accessdata.fda.gov |
| April 10, 2009 | K090189 | ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| April 6, 2009 | K082806 | SPINNING SPIROS, MODEL CH-2000 | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| March 13, 2009 | K090610 | HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM | DRG | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| August 28, 2008 | K081361 | CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| May 13, 2008 | K080007 | GRADUATED ADAPTER WITH CLAVE | EZD | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| February 13, 2008 | K080077 | CLAVE STOPCOCK | FMG | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| September 19, 2007 | K070979 | PULL TAB SQUEEZE FLUSH | KRA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| March 20, 2007 | K070532 | SPIROS | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| October 5, 2006 | K061585 | OPTICATH CENTRAL VENOUS OXIMETRY CATHETER | DQE | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| September 19, 2006 | K061573 | TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT | DRS | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| August 4, 2006 | K061450 | HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS | DQE | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| February 17, 2006 | K052828 | DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT) | DRS | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| September 1, 2004 | K042182 | Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432 | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| January 9, 1998 | K974589 | SMARTVALVE | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| June 24, 1997 | K970855 | CLAVE CONNECTOR | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| April 2, 1997 | K964435 | PRIMARY IV SET | FMG | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| February 10, 1997 | K961552 | CVP POLYURETHANE CATHETER | FOZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| October 7, 1995 | K953573 | ICU STOPCOK WITH EXTENSION TUBING | FMG | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| December 13, 1994 | K941978 | HIGH PRESSURE TUBING | DQO | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| September 22, 1994 | K932141 | CARDIAC CATHETERIZATION KIT | DQO | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| June 13, 1994 | K941254 | DYE MANAGEMENT SYSTEM | DQO | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| October 25, 1993 | K932188 | SAFESET RESERVOIR | KRA | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| June 18, 1993 | K923966 | SYRINGE ADAPTOR | LHI | Substantially Equivalent | Excel Medical, Inc. | accessdata.fda.gov |
| September 21, 1992 | K915571 | CLAVE CONNECTOR | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| June 3, 1992 | K914299 | CARDIAC CATHERIZATION KIT | DQO | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| April 6, 1992 | K914988 | 500 INFUSER | FRN | Substantially Equivalent | Excel Medical, Inc. | accessdata.fda.gov |
| February 11, 1992 | K913804 | EXCELSIOR SINGLE LEAD DISPENSING SET | LHI | Substantially Equivalent | Excel Medical, Inc. | accessdata.fda.gov |
| February 7, 1992 | K915171 | LOPEZ VALVE TM II | KNT | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| April 25, 1991 | K905116 | PHARM-ASSIST | LHI | Substantially Equivalent | Excel Medical, Inc. | accessdata.fda.gov |
| December 13, 1988 | K884318 | THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM | KRB | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| May 25, 1988 | K874465 | SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD | DYG | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| August 12, 1983 | K831506 | DISP. TRANSDUCER W/MONITORING KIT TRANS | DRS | Substantially Equivalent | Sorensen Research | accessdata.fda.gov |
| November 1, 1982 | K823007 | OPTICATH HEPARIN COATED, FLOW-DIRECT | DYG | Substantially Equivalent | Oximetrix, Inc. | accessdata.fda.gov |
| May 18, 1982 | K821057 | FLOW DIRECTED THERMAL-DILUTION INFUSION | DYG | Substantially Equivalent | Oximetrix, Inc. | accessdata.fda.gov |
| March 25, 1982 | K820674 | OPTICATH | DQE | Substantially Equivalent | Oximetrix, Inc. | accessdata.fda.gov |
| May 14, 1980 | K801048 | ACCUDYNAMIC | DRS | Substantially Equivalent | Sorensen Research | accessdata.fda.gov |
| October 1, 1979 | K791796 | ADDITIVE HINGE CAP | KPE | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
Compare with other makers
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Updated March 6, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.