# K053405: Bacstop

- Pathway: 510(k) (Traditional)
- Applicant: Elcam Medical Acal
- Decided: May 11, 2006 after 155 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: 2 generations back to K861563 (1986). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022895: Elcam Stopcocks and Manifolds, Medical Device Consultants, Inc. (2002) Summary page 3.
- K954970: Stopcock & Luer Lock Plug, Medex, Inc. (1996) Summary page 1.

## Most influential descendants
- K082106: Elcam Antimicrobial Closed Stopcocks (DSS and TSS) (2008), 0 descendants of its own
- K073396: Antimicrobial Ultrasite Value, Ultrasite AG (2008), 0 descendants of its own

## Indications for use
Elcam Antimicrobial Stopcock [or Manifold] is 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. Elcam Antimicrobial Stopcock [or Manifold] has 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/K053405
Methodology: https://510kreport.com/methodology