510(k) · Cleared
Recalled · 2010Solution Administration Sets with Capless Luer Activated Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · FPA Set, Administration, Intravascular
Cleared on Oct 19, 2000 after a 3-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 51 devices in its family, counting itself, have a Class I recall. 50 later devices descend from it. It has been recalled 18 times.
- Decided
- Oct 19, 2000
- Review
- 3 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 18
- Predicates
- 0
50 later devices descend from it, 5 citing it directly. 2 of the 51 devices in this family, counting this one, have a Class I recall.
- This deviceK003225 Solution Administration Sets with Capless Luer Activated ValveBaxter Healthcare Corp · 2000
- Descendant · cites it directly · 28 of its ownK120443 Neutral Luer Activated Device and Extension Sets with Neutral Luer…Baxter Healthcare Corporation - Renal Division · 2012
- Descendant · 2 generations on · 26 of its ownK132413 MZ1000Care Fusion · 2013
- Descendant · 3 generations on · 13 of its ownK140831 Maxzero Extension Set with Needless ConnectorCare Fusion · 2014
- Descendant · cites it directly · 11 of its ownK112893 Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter…Baxter Healthcare Corporation · 2011 · Recalled (Class I)
- Descendant · 3 generations on · 6 of its ownK170336 BD Nexiva Closed IV Catheter System (Single Port) with MaxZero…Becton, Dickinson and Company · 2017
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 50 · See all- K120443Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated DeviceBaxter Healthcare Corporation - Renal Division · 2012 · cites it directly28descendants
- K132413MZ1000Care Fusion · 2013 · 2 generations on26descendants
- K140831Maxzero Extension Set with Needless ConnectorCare Fusion · 2014 · 3 generations on13descendants
- K112893Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension SetsBaxter Healthcare Corporation · 2011 · cites it directly11descendants
- K170336BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless ConnectorBecton, Dickinson and Company · 2017 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003225 | Solution Administration Sets with Capless Luer Activated Valve | Baxter Healthcare Corp | 2000 | — |
| +1 | K120443 | Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated… | Baxter Healthcare Corporation - Renal Division | 2012 | — |
| +2 | K132413 | MZ1000 | Care Fusion | 2013 | — |
| +3 | K140831 | Maxzero Extension Set with Needless Connector | Care Fusion | 2014 | — |
| +1 | K112893 | Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension… | Baxter Healthcare Corporation | 2011 | Class I |
| +3 | K170336 | BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless… | Becton, Dickinson and Company | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 1 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 8 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 1 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (50)
See all 505 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120443 | Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated Device | 2012 | 28 |
| K112893 | Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension Sets Class I | 2011 | 11 |
| K072576 | Clearlink Antimicrobial Luer Activated Device (Lad) and Extension Sets with the… | 2007 | 4 |
| K040385 | Multiport Manifold Set with Swabable Valves, Model 9900 | 2004 | 3 |
| K103551 | Interlink S / Clearlink System / V-Link Lad with Vitalshield Protective Coating Non-Dehp… | 2011 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 9, 2010 | Not classified | Z-0158-2011 | Package design/selection | 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 of the pouch. |
| Sep 9, 2010 | Not classified | Z-0148-2011 | Package design/selection | 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 of the pouch. |
| Feb 16, 2007 | Not classified | Z-0618-2007 | Other | Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets. |
| Dec 15, 2005 | Not classified | Z-0625-06 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
The 5 latest of 18 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K112893Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension SetsBaxter Healthcare Corporation · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K243529Solution Administration SetsBaxter Healthcare Corporation · 2025 · 3 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K120443 (Baxter Healthcare Corporation - Renal Division, 2012) has gone furthest, with 28 descendants of its own.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
https://510kreport.com/device/K003225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003225: Solution Administration Sets with Capless Luer Activated Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003225
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026