510(k) · Cleared
ClearedIvex-2 Extension Set with Y-Injection Site (Modification)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · LHI Set, I.V. Fluid Transfer
Cleared on May 29, 1996 after a 148-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- May 29, 1996
- Review
- 148 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK960466 Ivex-2 Extension Set with Y-Injection Site (Modification)Abbott Laboratories · 1996
- Descendant · cites it directly · 2 of its ownK964850 Solution Administration Set with 0.22 Micron High Pressure Extended…Baxter Healthcare Corp · 1997 · Recalled
- Descendant · 2 generations on · 0 of its ownK153158 Solution Administration Sets with 0.2 Micron FilterBaxter Healthcare Corporation · 2015 · Recalled
- Descendant · cites it directly · 0 of its ownK994429 Venusa, LTD. Extension Set with FilterVenusa, Ltd. · 2000
Most influential descendants
Showing 3 of 3 · See all- K964850Solution Administration Set with 0.22 Micron High Pressure Extended Life FilterBaxter Healthcare Corp · 1997 · cites it directly2descendants
- K153158Solution Administration Sets with 0.2 Micron FilterBaxter Healthcare Corporation · 2015 · 2 generations on0descendants
- K994429Venusa, LTD. Extension Set with FilterVenusa, Ltd. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960466 | Ivex-2 Extension Set with Y-Injection Site (Modification) | Abbott Laboratories | 1996 | — |
| +1 | K964850 | Solution Administration Set with 0.22 Micron High Pressure Extended Life Filter | Baxter Healthcare Corp | 1997 | 5 |
| +2 | K153158 | Solution Administration Sets with 0.2 Micron Filter | Baxter Healthcare Corporation | 2015 | 2 |
| +1 | K994429 | Venusa, LTD. Extension Set with Filter | Venusa, Ltd. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2015 | 1 | 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.
Planning a device in LHI? 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 LHI device
- #1 K252987 ADRx™ Admixture Devicescore 12.4 · 4 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K964850 (Baxter Healthcare Corp, 1997) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LHI devicesLHI Set, I.V. Fluid Transfer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LHI
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LHI
196in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LHI
1in 2024
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · LHI
1,334in 2025
MAUDE reports naming product code LHI, 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 | 3 | 89 | 1 | 18 |
| 2008 | 4 | 154 | 3 | 27 |
| 2009 | 8 | 95 | 1 | 37 |
| 2010 | 5 | 139 | 3 | 49 |
| 2011 | 3 | 99 | 12 | 155 |
| 2012 | 5 | 127 | 0 | 529 |
| 2013 | 4 | 102 | 3 | 154 |
| 2014 | 6 | 63 | 0 | 155 |
| 2015 | 3 | 99 | 0 | 128 |
| 2016 | 3 | 159 | 1 (1) | 219 |
| 2017 | 5 | 56 | 1 | 536 |
| 2018 | 1 | — | 3 (3) | 1,499 |
| 2019 | 4 | 247 | 1 | 1,634 |
| 2020 | 3 | 189 | 0 | 1,171 |
| 2021 | 3 | 396 | 0 | 933 |
| 2022 | 6 | 278 | 2 | 1,834 |
| 2023 | 5 | 90 | 2 (2) | 1,047 |
| 2024 | 9 | 166 | 1 | 1,270 |
| 2025 | 6 | 196 | 0 | 1,334 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/K960466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960466: Ivex-2 Extension Set with Y-Injection Site (Modification).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960466
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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