Data / Medical devices / United States / Icu Medical, Inc.
Icu Medical, Inc.: FDA-registered device maker in San Diego, CA, United States, 19 510(k) clearances
Icu Medical, Inc. is registered with the FDA (registration 2024064) in San Diego, CA, United States. It lists 4 device types. The FDA files 19 510(k) clearances under its listings, the newest dated April 2, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2024064
- Address
- 13520 Evening Creek Drive North Suite 200, San Diego, CA, United States, 92128
- Owner or operator
- ICU MEDICAL, INC. (2025816)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 17, 2017
- Registered through
- 2026
- Brand names listed
- ICU Medical MedNet Medication Management Suite, Infusion System, LifeShield Infusion Safety Software Suite, Lifecare 5000 Infusion System, Lifecare PCA Infusion System, Lifecare PCA Infusion system, PLUM 360 Infusion System, PLUM A+ Infusion System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Infusion Safety Management Software | PHC | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Pump, Infusion | FRN | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Pump, Infusion, Pca | MEA | 2 | Specification developer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Specification developer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| April 2, 2026 | K252130 | LifeShield Infusion Safety Software Suite | PHC | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| April 2, 2025 | K242117 | LifeShield Infusion Safety Software Suite | PHC | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| April 2, 2025 | K242115 | Plum Duo Precision IV Pump | FRN | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| April 2, 2025 | K242114 | Plum Solo Precision IV Pump | FRN | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| August 24, 2023 | K223607 | Plum Duo Infusion System | FRN | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| August 24, 2023 | K223606 | LifeShield Infusion Safety Software Suite | PHC | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| March 28, 2017 | K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module | FRN | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| April 8, 2016 | K143612 | LifeCare PCA Infusion System | MEA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| January 16, 2015 | K141789 | PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE | FRN | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| July 8, 2014 | K141102 | HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE | FRN | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| March 5, 2012 | K110901 | SYMBIQ INFUSION AND ADMINSTRATION SET | FRN | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| April 24, 2007 | K070398 | HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391 | FRN | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| August 24, 2005 | K052052 | HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5 | FRN | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| October 18, 2004 | K042800 | LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE | MEA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| August 24, 2004 | K042081 | PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE | FRN | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| June 5, 2001 | K011442 | ABBOTT PLUM A+INFUSION PUMP, MODEL 11971 | FRN | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| April 6, 2001 | K010924 | MODIFICATION TO PLUM XL INFUSION PUMP | FRN | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| January 18, 1996 | K952799 | ABBOTT XL3M INFUSION PUMP | FRN | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| May 28, 1991 | K911401 | ABBOTT LIFECARE 5000 PUMP | FRN | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
Compare with other makers
- All makers of Infusion Safety Management Software
- All makers of Pump, Infusion
- All makers of Set, Administration, Intravascular
- All makers of Pump, Infusion, Pca
Updated April 2, 2026. 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.