# K081361: Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXX

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Aug 28, 2008 after 105 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 7 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K980580 (1998). 17 ancestors in all.
12 later devices descend from it; 2 cite it directly.
3 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970855: Clave Connector, Icu Medical, Inc. (1997) Summary page 1.
- K024239: Chemo Dispensing Pin, Model 12495, Abbott Laboratories (2003) Summary page 1.
- K070633: Genie, Model CH-200, Icu Medical, Inc. (2007) Summary page 1.
- K003730: Chemo-Aide Dispensing Pin, Baxter Healthcare Corp (2000) Summary page 1.
- K934591: Clave Vial Access Spike, Icu Medical, Inc. (1994) Summary page 1.
- K003513: Taxol Administration Set, Icu Medical, Inc. (2001) Summary page 1.
- K070532: Spiros, Icu Medical, Inc. (2007) Summary page 1.
- K974431: Chemo-Spike II Reconstitution Device, Medi-Dose, Inc. (1998) Summary page 1.
- K080989: Universal Vial Access Spike, Icu Medical, Inc. (2008) Summary page 1.
- K964435: Primary IV Set, Icu Medical, Inc. (1997) Summary page 1.
- K070856: Icu Medical Single-Use Syringe, Icu Medical, Inc. (2007) Summary page 1.

## Most influential descendants
- K131549: Chemolock, Chemolock Port (2013), 10 descendants of its own
- K141448: Tevadaptor Closed Drug Reconstitution and Transfer System (2015), 9 descendants of its own
- K192866: Chemfort CSTD (2020), 3 descendants of its own
- K201422: Arisure Closed System Drug Transfer Device (CSTD) (2021), 1 descendant of its own
- K180489: TEVADAPTOR Closed Drug Reconstitution and Transfer System (2018), 1 descendant of its own

## Recalls of this device
- May 12, 2026 · Class II · Z-3158-2026: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber 
- May 12, 2026 · Class II · Z-3160-2026: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber 
- Mar 16, 2021 · Class II · Z-1566-2021: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
- Mar 16, 2021 · Class II · Z-1565-2021: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
- Aug 31, 2020 · Class II · Z-0701-2021: Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous me
- Feb 21, 2019 · Class I · Z-1092-2019: There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.
- Feb 21, 2019 · Class I · Z-1093-2019: There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.

## Indications for use
The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System consists of 6 previously cleared components (CLAVE®, Spikes, SPIROSTM, GENIE TM, Vial Access, and Admin Sets) that can be combined into various configurations intended for use in the preparation and patient administration of cytotoxic medications.

Source page: https://510kreport.com/device/K081361
Methodology: https://510kreport.com/methodology