# K012157: Churchill Medical Systems Stopcock

- Pathway: 510(k) (Traditional)
- Applicant: Churchill Medical Systems, Inc.
- Decided: Sep 11, 2001 after 62 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: 1 generation back to K974083 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974083: Connecta Plus 1 and Connecta Plus 3 2-Way and 3-Way Stopcocks, Ohmeda Medical (1998) Summary page 1.

## Recalls of this device
- Jul 24, 2017 · Class II · Z-0682-2018: Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyve

## Indications for use
Churchill Medical Systems Stopcock is a valve for use in I.V. therapy and pressure monitoring to direct and control the flow of medical fluids.

Source page: https://510kreport.com/device/K012157
Methodology: https://510kreport.com/methodology