510(k) · Cleared
Recalled · 2005Huber Needle Extension Set with Standard Y-Injection Site, Interlink Y-Injection Site, Interlink T-Injection Site
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 Jun 26, 1996 as substantially equivalent to K950597 (Distronic Sterile Products, Inc., 1995) after a 69-day review. Its family tree reaches back 1 generation to 1995. It has been recalled 9 times.
- Decided
- Jun 26, 1996
- Review
- 69 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 9
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950597 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK950597 Core-Resistant Huber Infusion Set with Y-SiteDistronic Sterile Products, Inc. · 1995
- This deviceK961495 Huber Needle Extension Set with Standard Y-Injection Site, Interlink…Baxter Healthcare Corp · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950597 | Core-Resistant Huber Infusion Set with Y-Site | Distronic Sterile Products, Inc. | 1995 | — |
| 0 (this device) | K961495 | Huber Needle Extension Set with Standard Y-Injection Site, Interlink… | Baxter Healthcare Corp | 1996 | — |
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? (3)
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 |
|---|---|---|---|
| * | K950597 | Core-Resistant Huber Infusion Set with Y-SiteSummary page 1…Statement of Intended Use: Baxter’s proposed Huber Needle Extension Sets have the same intended use as the Micro-Med, Inc. Core Resistant Huber Infusion Sets covered by K950597. They are intended for the administration of solutions and drugs into vascular implant ports. The proposed Huber Needle Extension… | 1995 |
| * | — | Baxter Solution Administration Sets with InterLink® Injection Site Named without a submission number | |
| * | — | Baxter InterLink® T-Connector Extension Sets Named without a submission number | |
| † | K925126 | Interlink (TM) Injection Site | 1993 |
| † | K883638 | Safesite Injection Site and Blunt Cannula | 1988 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 3, 2005 | Not classified | Z-1435-05 | Other | The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication. |
| Aug 3, 2005 | Not classified | Z-1432-05 | Other | The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication. |
| Aug 3, 2005 | Not classified | Z-1433-05 | Other | The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication. |
| Aug 3, 2005 | Not classified | Z-1439-05 | Other | The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication. |
| Aug 3, 2005 | Not classified | Z-1434-05 | Other | The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication. |
| Aug 3, 2005 | Not classified | Z-1436-05 | Other | The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication. |
| Aug 3, 2005 | Not classified | Z-1437-05 | Other | The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication. |
| Aug 3, 2005 | Not classified | Z-1438-05 | Other | The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication. |
| May 31, 2005 | Not classified | Z-1048-05 | Other | Some of the product code 2N3709 extension sets with Y-injections sites were placed in packages labeled as product code 2N3703 extension sets which do not have Y-injection sites. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K950597.
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?
Baxter’s proposed Huber Needle Extension Sets have the same intended use as the Micro-Med, Inc. Core Resistant Huber Infusion Sets covered by K950597. They are intended for the administration of solutions and drugs into vascular implant ports. The proposed Huber Needle Extension Sets with InterLink® Y-Site or InterLink® T-Site, like other products containing the InterLink® injection site are designed to reduce the tisk of accidental needle sticks when used in conjunction with the InterLink® cannula, as part of a “needleless” IV access system.
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/K961495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961495: Huber Needle Extension Set with Standard Y-Injection Site, Interlink Y-Injection Site, Interlink T-Injection Site.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961495
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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