ClearanceBrief
510(k) K081361 ยท FPA Set, Administration, Intravascular

CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX

ApplicantIcu Medical, Inc., Salt Lake City UT, US
DecisionSubstantially Equivalent, Aug 28, 2008
ReceivedMay 15, 2008
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K081361

DateFirm and productCodeLinked 510(k)
Sep 11, 2026ICU Medical, Inc.
Oncology sets with drip chambers
Open, Classified		 FPANone listed
Sep 11, 2026ICU Medical, Inc.
IV Sets with drip chambers
Open, Classified		 FPANone listed
Mar 16, 2021ICU Medical, Inc.
REF CH3397 Oncology Kit w/Spiros, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
Open, Classified		 FPANone listed
Mar 16, 2021ICU Medical, Inc.
REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
Open, Classified		 FPANone listed
Aug 31, 2020ICU Medical, Inc.
5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip Chamber, Clave, Spiros, REF: CH3035; 40" (102 cm) Appx 4.5 ml,
Open, Classified		 FPANone listed
Apr 15, 2019ICU Medical, Inc.
icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the tran
Terminated		 FPANone listed
Apr 15, 2019ICU Medical, Inc.
icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the trans
Terminated		 FPANone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.