# K082106: Elcam Antimicrobial Closed Stopcocks (DSS and TSS)

- Pathway: 510(k) (Special)
- Applicant: Elcam Medical Acal
- Decided: Oct 2, 2008 after 69 days
- Product code: FMG (Stopcock, I.V. Set)
- 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 K862691 (1986). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053405: Bacstop, Elcam Medical Acal (2006) Summary page 1.
- K060231: Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated Swabable-Stopcock, Elcam Medical Acal (2006) Summary page 1.

## Indications for use
Elcam Antimicrobial Closed Stopcocks (DSS and TSS) are indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion. Both configurations have a feature of an antimicrobial agent using a compound containing silver. The inclusion of an antimicrobial agent into the material formulation is intended to prevent/reduce the growth of contaminants on the device. The device is NOT intended to be used as a treatment for patient infections.

Source page: https://510kreport.com/device/K082106
Methodology: https://510kreport.com/methodology