Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Icu Medical, Inc. · Predicate Candidate Screening
66 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
111 daysmedian FDA review time
284 days90th percentile
66clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252130 | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | 2026-04-02 | 269 | 0 |
| K252006 | OTTO™ Disinfecting Cap | Icu Medical, Inc. | 2026-03-27 | 273 | 0 |
| K251980 | ClaveQS™ Bag | Icu Medical, Inc. | 2026-03-20 | 266 | 0 |
| K250616 | Clave™ Neutral-Displacement Needlefree Connectors | Icu Medical, Inc. | 2025-06-05 | 97 | 0 |
| K242117 | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | 2025-04-02 | 257 | 2 |
| K242114 | Plum Solo™ Precision IV Pump | Icu Medical, Inc. | 2025-04-02 | 257 | 3 |
| K242115 | Plum Duo™ Precision IV Pump | Icu Medical, Inc. | 2025-04-02 | 257 | 2 |
| K243985 | Rio™ Drug Reconstitution Transfer Device | Icu Medical, Inc. | 2025-01-22 | 30 | 0 |
| K223607 | Plum Duo™ Infusion System | Icu Medical, Inc. | 2023-08-24 | 265 | 6 |
| K223606 | LifeShield™ Infusion Safety Software Suite | Icu Medical, Inc. | 2023-08-24 | 265 | 1 |
| K173477 | ChemoCLAVE Cytotoxic Medication Preparation and Delivery Sys | Icu Medical, Inc. | 2018-08-31 | 291 | 0 |
| K170110 | Diana Medication Transfer Set | Icu Medical, Inc. | 2018-08-10 | 575 | 0 |
| K152006 | Cogent Hemodynamic Monitoring System | Icu Medical, Inc. | 2016-05-05 | 289 | 0 |
| K151969 | Hospira Extension Sets | Icu Medical, Inc. | 2016-01-19 | 187 | 0 |
| K140129 | PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VE | Icu Medical, Inc. | 2014-07-02 | 167 | 0 |
| K131549 | CHEMOLOCK, CHEMOLOCK PORT | Icu Medical, Inc. | 2013-07-26 | 58 | 42 |
| K100576 | HIGH PRESSURE SETS-400 PSI | Icu Medical, Inc. | 2010-12-17 | 291 | 0 |
| K100434 | CLAVE NEUTRON | Icu Medical, Inc. | 2010-07-09 | 143 | 0 |
| K090189 | ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE | Icu Medical, Inc. | 2009-04-10 | 74 | 0 |
| K082806 | SPINNING SPIROS, MODEL CH-2000 | Icu Medical, Inc. | 2009-04-06 | 194 | 0 |
| K082836 | ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES | Icu Medical, Inc. | 2009-02-25 | 152 | 0 |
| K081361 | CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYS | Icu Medical, Inc. | 2008-08-28 | 105 | 2 |
| K080007 | GRADUATED ADAPTER WITH CLAVE | Icu Medical, Inc. | 2008-05-13 | 132 | 0 |
| K080989 | UNIVERSAL VIAL ACCESS SPIKE | Icu Medical, Inc. | 2008-05-02 | 25 | 0 |
| K080077 | CLAVE STOPCOCK | Icu Medical, Inc. | 2008-02-13 | 33 | 0 |
| K070856 | ICU MEDICAL SINGLE-USE SYRINGE | Icu Medical, Inc. | 2007-10-05 | 191 | 0 |
| K070979 | PULL TAB SQUEEZE FLUSH | Icu Medical, Inc. | 2007-09-19 | 166 | 0 |
| K070633 | GENIE, MODEL CH-200 | Icu Medical, Inc. | 2007-06-05 | 90 | 0 |
| K063784 | DYE MANAGEMENT SYSTEM | Icu Medical, Inc. | 2007-04-16 | 116 | 0 |
| K070532 | SPIROS | Icu Medical, Inc. | 2007-03-20 | 22 | 0 |
| K052594 | WILLCARE, MODEL GW-1020 | Icu Medical, Inc. | 2006-02-10 | 142 | 0 |
| K053106 | TEGO, MODEL D1000 | Icu Medical, Inc. | 2006-01-10 | 67 | 2 |
| K052865 | HOSPIRA CATH LAB CONVENIENCE KITS | Icu Medical, Inc. | 2005-12-22 | 72 | 3 |
| K051437 | CML 1000 | Icu Medical, Inc. | 2005-08-03 | 63 | 0 |
| K042182 | Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432 | Icu Medical, Inc. | 2004-09-01 | 21 | 0 |
| K040710 | TEGO NEEDLE FREE ACCESS ACCESS DEVICE | Icu Medical, Inc. | 2004-08-11 | 146 | 0 |
| K041410 | PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118 | Icu Medical, Inc. | 2004-07-28 | 62 | 0 |
| K033290 | TALON INFUSION SET, MODEL IP XXXX | Icu Medical, Inc. | 2004-04-12 | 181 | 3 |
| K021692 | CLC2000 CATHETER PATENCY DEVICE | Icu Medical, Inc. | 2003-12-04 | 561 | 0 |
| K003513 | TAXOL ADMINISTRATION SET | Icu Medical, Inc. | 2001-01-11 | 58 | 0 |
| K000472 | POSI-LINK | Icu Medical, Inc. | 2000-05-10 | 86 | 0 |
| K983559 | BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR | Icu Medical, Inc. | 1998-12-24 | 72 | 0 |
| K974589 | SMARTVALVE | Icu Medical, Inc. | 1998-01-09 | 31 | 0 |
| K973167 | POSITIVE PRESSURE CONNECTOR | Icu Medical, Inc. | 1997-11-17 | 84 | 0 |
| K972712 | CORE RESISTANT HUBER INFUSION SETS | Icu Medical, Inc. | 1997-10-01 | 72 | 0 |
| K970855 | CLAVE CONNECTOR | Icu Medical, Inc. | 1997-06-24 | 106 | 51 |
| K964435 | PRIMARY IV SET | Icu Medical, Inc. | 1997-04-02 | 148 | 25 |
| K954813 | ICU EXTENSION KIT | Icu Medical, Inc. | 1995-11-29 | 41 | 0 |
| K953573 | ICU STOPCOK WITH EXTENSION TUBING | Icu Medical, Inc. | 1995-10-07 | 68 | 0 |
| K941190 | CLAVE NEEDLE-LESS CONNECTOR OPEN EXTENSION SET | Icu Medical, Inc. | 1995-01-31 | 323 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda