# K080077: Clave Stopcock

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Feb 13, 2008 after 33 days
- Product code: FMG (Stopcock, I.V. Set)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K941190 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941190: Clave Needle-Less Connector Open Extension Set, Icu Medical, Inc. (1995) Summary page 1.
- K970855: Clave Connector, Icu Medical, Inc. (1997) Summary page 1.
- K953573: Icu Stopcok with Extension Tubing, Icu Medical, Inc. (1995) Summary page 1.

## Recalls of this device
- Jul 6, 2020 · Class II · Z-0212-2021: 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-0213-2021: 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-0250-2021: 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-0220-2021: 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
The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids that flow from a container to a patient's vascular system through a needle or catheter inserted into a vein or artery. This device is a four-way stopcock with an integral CLAVE side-port for closed, needleless access to the patient tubing or other fluid container.

Source page: https://510kreport.com/device/K080077
Methodology: https://510kreport.com/methodology