510(k) · Cleared
ClearedV-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial Luer Activated Device
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 Aug 4, 2008 as substantially equivalent to K072576 (Baxter Healthcare Corp, 2007) after an 89-day review. Its family tree reaches back 3 generations to 1992. 3 later devices descend from it.
- Decided
- Aug 4, 2008
- Review
- 89 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K915571 (1992). 5 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK915571 Clave ConnectorIcu Medical, Inc. · 1992 · Recalled
- 2 generations backK973916 NP Medical Capless Luer Activated ValveNp Medical, Inc. · 1998
- 1 generation backK072576 Clearlink Antimicrobial Luer Activated Device (Lad) and Extension…Baxter Healthcare Corp · 2007
- This deviceK081289 V-Link Antimicrobial Luer Activated Device and Extension Sets with…Baxter Healthcare Corp · 2008
- Descendant · cites it directly · 0 of its ownK103551 Interlink S / Clearlink System / V-Link Lad with Vitalshield…Baxter Healthcare Corp · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK093489 IN Vision-Plus Nano with Neutral Advantage TechnologyRymed Technologies, Inc. · 2010 · Recalled
- Descendant · cites it directly · 0 of its ownK090189 Antimicrobial Clave, Models AG Clave, AG MicroclaveIcu Medical, Inc. · 2009
Most influential descendants
Showing 3 of 3 · See all- K103551Interlink S / Clearlink System / V-Link Lad with Vitalshield Protective Coating Non-Dehp…Baxter Healthcare Corp · 2011 · cites it directly0descendants
- K093489IN Vision-Plus Nano with Neutral Advantage TechnologyRymed Technologies, Inc. · 2010 · cites it directly0descendants
- K090189Antimicrobial Clave, Models AG Clave, AG MicroclaveIcu Medical, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K915571 | Clave Connector | Icu Medical, Inc. | 1992 | 3 |
| −2 | K973916 | NP Medical Capless Luer Activated Valve | Np Medical, Inc. | 1998 | — |
| −1 | K072576 | Clearlink Antimicrobial Luer Activated Device (Lad) and Extension Sets with… | Baxter Healthcare Corp | 2007 | — |
| 0 (this device) | K081289 | V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link… | Baxter Healthcare Corp | 2008 | — |
| +1 | K103551 | Interlink S / Clearlink System / V-Link Lad with Vitalshield Protective… | Baxter Healthcare Corp | 2011 | 1 |
| +1 | K093489 | IN Vision-Plus Nano with Neutral Advantage Technology | Rymed Technologies, Inc. | 2010 | 1 |
| +1 | K090189 | Antimicrobial Clave, Models AG Clave, AG Microclave | Icu Medical, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 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 |
|---|---|---|---|
| * | K072576 | Clearlink Antimicrobial Luer Activated Device (Lad) and Extension Sets with the…Summary page 2…k)s Device Company Previous 510(k) Clearance date CLEARLINK Antimicrobial Luer Baxter K072576 November 6, Activated Device and Extension Sets Healthcare 2007 with CLEARLINK Ant… | 2007 |
What descends from it? (3)
3 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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K103551 (Baxter Healthcare Corp, 2011) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K072576.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
Intended for use with a vascular access device for the administration of drugs and solutions. The V-Link Antimicrobial Luer Activated Device is an in-line injection site which can be connected to standard male Luer adapters (e.g., syringes or sets) for the continuous or intermittent fluid administration or the withdrawal of fluids.
The V-Link Antimicrobial Luer Activated Device contains an antimicrobial agent (metallic silver) that may reduce the growth of microorganisms on the coated surfaces of the V-Link device. The antimicrobial agent is not intended to be used as a treatment for existing infections.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081289 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081289: V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial Luer Activated Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081289
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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