# K100576: High Pressure Sets-400 Psi

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Dec 17, 2010 after 291 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K911884 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061285: Smartsite Needle Free Valve Administration Sets, Cardinal Health, Alaris Products (2006) Summary page 1.
- K941978: High Pressure Tubing, Abbott Laboratories (1994) Summary page 1.
- K963749: High Pressure Injection Lines, Maxxim Medical (1996) Summary page 1.

## Recalls of this device
- 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 
- Aug 1, 2022 · Class II · Z-1720-2022: Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
- Jul 6, 2020 · Class II · Z-0193-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
- Jul 6, 2020 · Class II · Z-0192-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
- Jul 6, 2020 · Class II · Z-0197-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
- Jul 6, 2020 · Class II · Z-0201-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
- Jul 6, 2020 · Class II · Z-0204-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
- Oct 4, 2019 · Class II · Z-1916-2020: There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could 

## Indications for use
The high pressure extension set is a device used as conduit tubing to deliver fluids from an electronic or manual injector and may also be used as connector tubing to provide a sterile fluid pathway between two devices. Fluids may include: Contrast media {at 10mL/second) or other medications, and blood or blood products as the physician may prescribe. The fluids are administered through a cannula or catheter placed in a vein or artery. The incorporation of ICU proprietary connectors such as the CLAVE; MicroCLAVE; Y-CLAVE; and CLC2000 with the extension sets, allows for needleless connectivity to other devices via unlversal luer connection. The maximum pressure is 400 psi and other ancillary devices must also be rated for pressure up to 400 psi.

Source page: https://510kreport.com/device/K100576
Methodology: https://510kreport.com/methodology