510(k) · Cleared
Recalled · Class II · 2021Ivac Needle Free Valve Administration Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Y · FPA Set, Administration, Intravascular
Cleared on Apr 4, 1996 after a 76-day review. The FDA summary names its predicate without a number. 20 later devices descend from it. It has been recalled 7 times.
- Decided
- Apr 4, 1996
- Review
- 76 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 7
- Predicates
- 0
20 later devices descend from it, 4 citing it directly.
- This deviceK960280 Ivac Needle Free Valve Administration SetsY · 1996
- Descendant · cites it directly · 11 of its ownK970485 Smartsite Access PinIvac Medical Systems · 1997 · Recalled
- Descendant · cites it directly · 6 of its ownK061285 Smartsite Needle Free Valve Administration SetsCardinal Health, Alaris Products · 2006 · Recalled
- Descendant · 2 generations on · 5 of its ownK052790 Smartsite Vented Vial Access Device, Model TBDCardinal Health, Alaris Products · 2005
- Descendant · 2 generations on · 3 of its ownK002689 Swabsite Swabbable Valve, Model 245000Quest Medical, Inc. · 2001
- Descendant · 3 generations on · 1 of its ownK151963 SmartSite Vented Vial Access DeviceYukon Medical, LLC · 2015
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K970485Smartsite Access PinIvac Medical Systems · 1997 · cites it directly11descendants
- K061285Smartsite Needle Free Valve Administration SetsCardinal Health, Alaris Products · 2006 · cites it directly6descendants
- K052790Smartsite Vented Vial Access Device, Model TBDCardinal Health, Alaris Products · 2005 · 2 generations on5descendants
- K002689Swabsite Swabbable Valve, Model 245000Quest Medical, Inc. · 2001 · 2 generations on3descendants
- K151963SmartSite Vented Vial Access DeviceYukon Medical, LLC · 2015 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960280 | Ivac Needle Free Valve Administration Sets | Y | 1996 | — |
| +1 | K970485 | Smartsite Access Pin | Ivac Medical Systems | 1997 | 3 |
| +1 | K061285 | Smartsite Needle Free Valve Administration Sets | Cardinal Health, Alaris Products | 2006 | 2 |
| +2 | K052790 | Smartsite Vented Vial Access Device, Model TBD | Cardinal Health, Alaris Products | 2005 | — |
| +2 | K002689 | Swabsite Swabbable Valve, Model 245000 | Quest Medical, Inc. | 2001 | — |
| +3 | K151963 | SmartSite Vented Vial Access Device | Yukon Medical, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FPA? 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | ICU Medical, Inc. Clave Connector Named without a submission number |
What descends from it? (20)
See all 204 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 2, 2021 | Class II | Z-2460-2021 | Process control | Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not… |
| Aug 2, 2021 | Class II | Z-2466-2021 | Process control | Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not… |
| Aug 2, 2021 | Class II | Z-2467-2021 | Process control | Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not… |
| Oct 9, 2015 | Class II | Z-0221-2016 | Process control | CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues. |
| Jan 13, 2015 | Class II | Z-1053-2015 | Under Investigation by firm | CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues. |
| Mar 19, 2014 | Class II | Z-1459-2014 | Nonconforming Material/Component | Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port. |
| Jan 22, 2014 | Class II | Z-0925-2014 | Under Investigation by firm | CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connection issues. The affected SmartSite connector lots may unintentionally disconnect from a female luer, may be difficult to disconnect from a… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K970485 (Ivac Medical Systems, 1997) has gone furthest, with 11 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) | — |
What is it indicated for?
The intended use for the IVAC Needle Free Valve administration sets is to allow IV fluid delivery of a wide range of fluids. The needle free valve allows the user to add medication into the primary line without the use of a needle.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960280 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960280: Ivac Needle Free Valve Administration Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960280
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026