# K141254: Elcam Stopcocks and Manifolds

- Pathway: 510(k) (Special)
- Applicant: Elcam Medical Acal
- Decided: Jul 30, 2014 after 77 days
- Product code: FMG (Stopcock, I.V. Set)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K862691 (1986). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 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 2.

## Most influential descendants
- K223499: Three Way Stop Cock (2023), 0 descendants of its own

## Recalls of this device
- May 10, 2018 · Class II · Z-0155-2022: Product has a lack of sterility assurance

## Indications for use
Elcamn Stopcocks and Manifolds with Safe2 Rotator 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.

Source page: https://510kreport.com/device/K141254
Methodology: https://510kreport.com/methodology