# K121554: Q-Flo Closed Male Luer Connector

- Pathway: 510(k) (Traditional)
- Applicant: Us Fusion, LLC. Dba Truecare Biomedix-USA
- Decided: Jun 8, 2012 after 14 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
Longest line of descent: 3 generations back to K883614 (1988). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053049: Alaris Safety Male Luer, Cardinal Health, Alaris Products (2006) Summary page 1.
- K070532: Spiros, Icu Medical, Inc. (2007) Summary page 1.

## Indications for use
The Q-FoTM Closed Male Luer Connector is intended for use by healthcare professionals for connection with standard open female luers when reconstituting, dispensing/transferring, administering, and disposal of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, as well as non-hazardous fluids.

Source page: https://510kreport.com/device/K121554
Methodology: https://510kreport.com/methodology