# K961225: Continuflo Solution Set/Secondary Medication Set

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jun 21, 1996 after 84 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 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) Current Baxter Solution Administration Sets: named in the summary without a submission number

## Most influential descendants
- K142011: Solution Set/Extension Set (2014), 1 descendant of its own
- 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
- K150860: Nitroglycerin Sets with DUO-VENT Spike (2015), 0 descendants of its own

## Recalls of this device
- Dec 12, 2019 · Class II · Z-0794-2020: Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the
- Dec 12, 2019 · Class II · Z-0793-2020: Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the
- Dec 6, 2011 · Not classified · Z-0475-2012: 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 
- Jul 21, 2011 · Not classified · Z-2920-2011: The Solution Sets are being recalled because the position of the slide clamp and roller clamp may have been reversed during assembly. The reversed orientation of the slide clamp and roller clamp will 
- 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.
- Jul 16, 2003 · Not classified · Z-1152-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.

Source page: https://510kreport.com/device/K961225
Methodology: https://510kreport.com/methodology