# K171101: Closed Male Luer

- Pathway: 510(k) (Traditional)
- Applicant: Yukon Medical
- Decided: Jun 2, 2017 after 50 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K240761: Arisure® Closed Male Luer with Spike Adapter (YM060) (2025), 0 descendants of its own

## Indications for use
The Closed Male Luer (CML) is a single use, sterile, non-pyrogenic, swab-able, bi-directional valve intended for use as an accessory to an Intravascular Administration Set. The Closed Male Luer provides access for the administration of fluids from a container to a patient’s vascular system through the administration needle or catheter which is inserted into the vein or artery.

Source page: https://510kreport.com/device/K171101
Methodology: https://510kreport.com/methodology