# K100434: Clave Neutron

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Jul 9, 2010 after 143 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K942988 (1995). 7 ancestors in all.
28 later devices descend from it; 2 cite it directly.
0 of 36 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.
- K021692: CLC2000 Catheter Patency Device, Icu Medical, Inc. (2003) Summary page 1.
- K083723: A6 Luer Access Device, B.Braun Medical, Inc. (2009) Summary page 1.

## Most influential descendants
- K132413: MZ1000 (2013), 26 descendants of its own
- K140831: Maxzero Extension Set with Needless Connector (2014), 13 descendants of its own
- K170336: BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector (2017), 6 descendants of its own
- K183399: BD Nexiva Closed IV Catheter System (2019), 5 descendants of its own
- K162804: Q2 Low Pressure Power Injection Extension Set (2017), 4 descendants of its own

## Recalls of this device
- Aug 1, 2022 · Class II · Z-1719-2022: 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-0182-2021: 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-0261-2021: 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.

## Indications for use
CLAVE Neutron is a normally closed, bidirectional connector intended for use as an accessory to an intravascular catheter placed in the vein or artery. The device may be used for the administration of blood and fluids to patients, including pediatrics and immunocompromised patients. The device may also be used with power injector procedures up to 10mL per second of contrast media and a maximum pressure of 350psi. The device incorporates a technology that will prevent fluid displacement resulting from the following: Connection or disconnection of a luer; syringe plunger compression; patient vascular pressure changes, such as coughing or sneezing; and IV solution container run-dry. The CLAVE Neutron incorporates a pre-slit septum that does not require the use of needles and will therefore passively aid in the reduction of needlestick injuries.

Source page: https://510kreport.com/device/K100434
Methodology: https://510kreport.com/methodology