# K962581: Stopcock Manifold Gangs

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Aug 28, 1996 after 58 days
- Product code: FMG (Stopcock, I.V. Set)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Medex, Inc. Ultra® Stopcock: named in the summary without a submission number
- (no number) Medex, Inc. Stopcock Manifold Gangs: named in the summary without a submission number

## Most influential descendants
- K130245: Large Bore Stopcock with Rotating Male Luer Lock/Large Bore Stopcock with Extension Set, Gang Large Bore Stopcock Manifo (2013), 1 descendant of its own
- K223175: lntravascular Administration Sets with Stopcock and Manifold (2023), 0 descendants of its own
- K982368: Manifold with Extension Set (1998), 0 descendants of its own

## Recalls of this device
- Dec 6, 2011 · Not classified · Z-0469-2012: During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking 
- Dec 6, 2011 · Not classified · Z-0470-2012: During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking 
- Dec 6, 2011 · Not classified · Z-0479-2012: During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking 
- Dec 6, 2011 · Not classified · Z-0480-2012: During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking 
- May 17, 2011 · Not classified · Z-2623-2011: There is the potential for pinholes and tears in the individual packaging of the stopcocks, compromising the sterility of the product.
- Oct 28, 2010 · Not classified · Z-0587-2011: Rotating the handle on the 3-Way Large Bore Stopcock past the stop can cause the stopcock to leak. A leak can lead to under-infusion or interruption of critical life-sustaining therapy.
- Oct 28, 2010 · Not classified · Z-0586-2011: Rotating the handle on the 3-Way Large Bore Stopcock past the stop can cause the stopcock to leak. A leak can lead to under-infusion or interruption of critical life-sustaining therapy.
- Sep 9, 2010 · Not classified · Z-0151-2011: During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties o
- Dec 15, 2005 · Not classified · Z-0654-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0655-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0656-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0646-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0653-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Feb 28, 2005 · Not classified · Z-0845-05: Possible occlusion of the Clearlink injection site valve due to inadequate silicone lubrication of the slit in the upper seal of the valve.

## Indications for use
These pre-assembled stopcock gangs provide multiple access sites into a common fluid path for the administration of drugs and solutions.

Source page: https://510kreport.com/device/K962581
Methodology: https://510kreport.com/methodology