# K974083: Connecta Plus 1 and Connecta Plus 3 2-Way and 3-Way Stopcocks

- Pathway: 510(k) (Traditional)
- Applicant: Ohmeda Medical
- Decided: Jan 13, 1998 after 76 days
- Product code: FMG (Stopcock, I.V. Set)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Connecta® TH (through hole) 2-way and 3-way Infusion/Pressure Monitoring Stopcocks: named in the summary without a submission number

## Most influential descendants
- K070143: JMS Planecta Stopcock (2007), 0 descendants of its own
- K012157: Churchill Medical Systems Stopcock (2001), 0 descendants of its own

## Recalls of this device
- May 21, 2026 · Class II · Z-2514-2026: Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical us
- Feb 20, 2025 · Class II · Z-1509-2025: Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)
- May 9, 2022 · Class II · Z-1439-2022: May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusi
- May 9, 2022 · Class II · Z-1434-2022: May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusi
- May 9, 2022 · Class II · Z-1436-2022: May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusi
- May 9, 2022 · Class II · Z-1433-2022: May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusi
- May 9, 2022 · Class II · Z-1441-2022: May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusi
- May 9, 2022 · Class II · Z-1432-2022: May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusi
- May 9, 2022 · Class II · Z-1437-2022: May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusi
- May 9, 2022 · Class II · Z-1435-2022: May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusi
- May 9, 2022 · Class II · Z-1431-2022: May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusi
- May 9, 2022 · Class II · Z-1440-2022: May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusi
- May 9, 2022 · Class II · Z-1438-2022: May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusi

## Indications for use
Connecta® Plus 1 and Connecta® Plus 3 2-way and 3-way Stopcocks are control valves for use in I.V. therapy and hemodynamic pressure monitoring. They are added to IV cannula or extension tubing sets for simultaneous or alternate administration of IV drugs, fluids, and blood, or for blood sampling. They can also be used in areas in which solution flow requires control. Alternatively, they are used for hemodynamic monitoring via an arterial cannula and a central venous catheter.

Source page: https://510kreport.com/device/K974083
Methodology: https://510kreport.com/methodology