# K003225: Solution Administration Sets with Capless Luer Activated Valve

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare Corp
- Decided: Oct 19, 2000 after 3 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
50 later devices descend from it; 5 cite it directly.
2 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K120443: Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated Device (2012), 28 descendants of its own
- K132413: MZ1000 (2013), 26 descendants of its own
- K140831: Maxzero Extension Set with Needless Connector (2014), 13 descendants of its own
- K112893: Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension Sets (2011), 11 descendants of its own
- K170336: BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector (2017), 6 descendants of its own

## Recalls of this device
- Sep 9, 2010 · Not classified · Z-0158-2011: 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
- Sep 9, 2010 · Not classified · Z-0148-2011: 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
- Feb 16, 2007 · Not classified · Z-0618-2007: Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets.
- Dec 15, 2005 · Not classified · Z-0625-06: 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-0651-06: 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-0650-06: 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.
- Apr 28, 2004 · Not classified · Z-0193-05: Inadequate directions for use may have contributed to an increase in infection rates at a small number of customers beginning use of the Clearlink needleless device.
- Jul 16, 2003 · Not classified · Z-1070-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Jul 16, 2003 · Not classified · Z-1157-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Jul 16, 2003 · Not classified · Z-1156-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Jul 16, 2003 · Not classified · Z-1169-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Jul 16, 2003 · Not classified · Z-1167-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Jul 16, 2003 · Not classified · Z-1161-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Jul 16, 2003 · Not classified · Z-1159-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Jul 16, 2003 · Not classified · Z-1158-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Jul 16, 2003 · Not classified · Z-1168-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Jul 16, 2003 · Not classified · Z-1166-03: 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/K003225
Methodology: https://510kreport.com/methodology