Data / Medical devices / United States / ICU Medical, Inc.
ICU Medical, Inc.: FDA-registered device maker in Dublin, OH, United States, 33 510(k) clearances
ICU Medical, Inc. is registered with the FDA (registration 1526863) in Dublin, OH, United States. It lists 40 device types. The FDA files 33 510(k) clearances under its listings, the newest dated October 24, 2019. 9 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1526863
- Address
- 6250 Shier Rings Rd, Dublin, OH, United States, 43016
- Owner or operator
- ICU Medical, Inc. (8020727)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- October 2, 1992
- Registered through
- 2026
- Brand names listed
- 1st Response Adult Manual Resuscita, ACAPELLA, ACE, AEROPHARM, Adapter, Anesthesia Breathing Bag, AsthmaKit, BACTERIAL 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 |
|---|---|---|---|---|---|---|
| October 24, 2019 | K181660 | Acapella Choice Blue Vibratory PEP Device | BWF | Substantially Equivalent | Smiths Medical | accessdata.fda.gov |
| July 25, 2019 | K183066 | The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD Technology-3 Fr, 4 Fr, and 5 Fr Model | DYB | Substantially Equivalent | Access Scientific, LLC | accessdata.fda.gov |
| September 26, 2018 | K181563 | The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology | DQY | Substantially Equivalent | Access Scientific, LLC | accessdata.fda.gov |
| September 18, 2018 | K182243 | The CVC WAND Safety Introducer with Valved Peelable Sheath | DYB | Substantially Equivalent | Access Scientific, LLC | accessdata.fda.gov |
| July 20, 2017 | K162219 | CADD® Infusion Disposables Portfolio with NRFit connectors | PWH | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| November 17, 2016 | K162322 | the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model | DYB | Substantially Equivalent | Access Scientific, LLC | accessdata.fda.gov |
| September 16, 2013 | K123957 | PNEUPAC PARAPAC PLUS | BTL | Substantially Equivalent | Smiths Medical International , Ltd. | accessdata.fda.gov |
| September 4, 2013 | K131148 | THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH | DYB | Substantially Equivalent | Access Scientific, LLC | accessdata.fda.gov |
| June 7, 2013 | K131300 | THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER | DYB | Substantially Equivalent | Access Scientific, LLC | accessdata.fda.gov |
| July 27, 2012 | K121748 | THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL | DYB | Substantially Equivalent | Access Scientific, Inc. | accessdata.fda.gov |
| July 15, 2011 | K111417 | THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER | DYB | Substantially Equivalent | Access Scientific, Inc. | accessdata.fda.gov |
| March 22, 2011 | K101422 | THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER | DYB | Substantially Equivalent | Access Scientific, Inc. | accessdata.fda.gov |
| March 15, 2007 | K070340 | SECURE ARTERIAL BLOOD SAMPLING SYSTEM | CBT | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| September 17, 2003 | K030570 | BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE | BTO | Substantially Equivalent | Portex , Ltd. | accessdata.fda.gov |
| May 20, 2002 | K020780 | TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP | GWM | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| February 27, 2002 | K014115 | 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX | BTM | Substantially Equivalent | Portex, Inc. | accessdata.fda.gov |
| June 18, 1998 | K981167 | STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT | CAF | Substantially Equivalent | Dhd Healthcare Corp. | accessdata.fda.gov |
| June 27, 1996 | K961404 | MX960 REUSABLE PRESSURE TRANSDUCER | DRS | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| April 22, 1996 | K954970 | STOPCOCK & LUER LOCK PLUG | FMG | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| September 21, 1995 | K952160 | INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA) | FPA | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| April 5, 1995 | K951129 | NOVATRANS II | DRS | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| February 10, 1995 | K943897 | NU-SITE | FPA | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| December 13, 1994 | K944208 | IV ADMINISTRATION SET FPA | FPA | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| August 16, 1994 | K942377 | TRANSTAR PRESSURE TRANSDUCER | DPT | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| August 11, 1994 | K940896 | MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE | MAV | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| November 27, 1991 | K913498 | MX927 BLOOD TRANSFER DEVICE | FMI | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| May 23, 1985 | K851986 | STOPCOCKS | FMG | Substantially Equivalent | Transamerica Delaval, Inc. | accessdata.fda.gov |
| April 28, 1983 | K831087 | MINI-VOL EXTENSION SET | FPA | Substantially Equivalent | Beech Medical, Inc. | accessdata.fda.gov |
| February 9, 1983 | K830152 | MINILOOP I.V. CONNECTORS & ADAPTOR | FPA | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| May 16, 1979 | K790407 | MICROTEC BACTERIAL FILTER | DRS | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| April 30, 1979 | K790408 | T-CONNECTOR | FPA | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| March 6, 1979 | K790314 | FLUID ADMINISTRATION SETS, 15 MICRON | FPB | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| February 22, 1979 | K782168 | 3-WAY STOPCOCK | FMG | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 10, 2023 | 93506 | Class II | Ongoing | Medex LOGICAL CATH LAB KIT, List Number M20754 | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication. | accessdata.fda.gov |
| May 4, 2015 | 71142 | Class II | Terminated | Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to admini | Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72'' Extension Set) where under-sized tubing was used in the production of 1 lot of product. | accessdata.fda.gov |
| March 24, 2008 | 47474 | Not yet classified | Terminated | Medex MX821L 72 inch (182.9cm) Administration Sets, Standard Drip, Sterile Single Use, Latex Free device packaged 25 units per case. Used to administer fluids. | Misbranded/mispackaged device was distributed. Product labeled to contain 72 inch Standard Drip ( IV) Administration Sets, actually contained 60 inch (IV) administration sets with a' Y' site. | accessdata.fda.gov |
| November 21, 2007 | 45889 | Not yet classified | Terminated | Smiths Medical, Add-On Kids Kit, Blood Sampling System, Product Code: MX4037, Smiths Medical ASD, Inc, Dublin, Ohio 43016 | Misbranded; The product codes are labeled incorrectly with a green promotional label for "New split septum sampling site. Only use needle-free access devices.......", however this product code contains a sampling site which is accessed with a shrouded needle, NOT with a needle-free access device | accessdata.fda.gov |
| October 4, 2006 | 36743 | Not yet classified | Terminated | Laborie Transducer Cartridge with Luer Lock Reference: DIS130 | Mislabeling: Product labeled with incorrect "Use Before" date and pouch labels missing lot number. (Incorrect dates-2006/07 or 2006/08; correct Use by dates-2009/08 for Lot 36H03M005 and 2009/07 for Lot 36G20M041 | accessdata.fda.gov |
| November 18, 2005 | 35122 | Not yet classified | Terminated | MX441B, CVP Manometer. The product is packaged in a cardboard box. The units are packed ten (10) per case. The product is labeled on the outer case with a stick-on label that reads in part, ''**medex Dublin, OH 43016 USA | The product is labeled as 'Latex Free', however,one of the components of the finished product may contain latex. | accessdata.fda.gov |
| November 18, 2005 | 35119 | Not yet classified | Terminated | MX6160R1, Custom CIPER (Comprehensive Intracranial Presssure Evaluation and Relief) System. The product is packaged in a tyvek pouch and is sold sterile. The product is labeled on the tyvek pouch with a stick-on label th | The product is labeled as 'Latex Free'; however, one of the components of the finished product may contain latex. | accessdata.fda.gov |
| October 20, 2004 | 30268 | Not yet classified | Terminated | MX20170: Pediatric 40 In Sampling Kit w/10cc syringe, MX20443: LogiCal Single Pressure Kit, MX20470: Pressure Monitoring Kit, MX20477: LogiCal Double Kit, MX20730: Double LogiCal Kit, MX20760: Neonatal 18'' Add-On Kit, M | Sampling port bodies on the device are cracking which can allow the sampling site to become dislodged from the body. | accessdata.fda.gov |
| July 12, 2004 | 29496 | Not yet classified | Terminated | IPI Ventilator Circuit with 2 Water Traps, product reorder no. 6066; SIngle Patient Use Only; Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641 | The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex. | accessdata.fda.gov |
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Updated January 17, 2024. 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.