510(k) · Cleared
Recalled · Class II · 2013Interlink S / Clearlink System / V-Link Lad with Vitalshield Protective Coating Non-Dehp Catheter Extension Set Kits,
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 Mar 25, 2011 as substantially equivalent to K861557 (Aplicare, Inc., 1986) and 3 other predicates after a 113-day review. Its family tree reaches back 4 generations to 1992. It has been recalled once.
- Decided
- Mar 25, 2011
- Review
- 113 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 4 generations to K915571 (1992). 7 ancestors in all, the oldest K861557 (1986). No later device cites it as a predicate yet.
- Root · 4 generations backK915571 Clave ConnectorIcu Medical, Inc. · 1992 · Recalled
- 3 generations backK973916 NP Medical Capless Luer Activated ValveNp Medical, Inc. · 1998
- 2 generations backK072576 Clearlink Antimicrobial Luer Activated Device (Lad) and Extension…Baxter Healthcare Corp · 2007
- 1 generation backK081289 V-Link Antimicrobial Luer Activated Device and Extension Sets with…Baxter Healthcare Corp · 2008
- This deviceK103551 Interlink S / Clearlink System / V-Link Lad with Vitalshield…Baxter Healthcare Corp · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915571 | Clave Connector | Icu Medical, Inc. | 1992 | 3 |
| −3 | K973916 | NP Medical Capless Luer Activated Valve | Np Medical, Inc. | 1998 | — |
| −2 | K072576 | Clearlink Antimicrobial Luer Activated Device (Lad) and Extension Sets with… | Baxter Healthcare Corp | 2007 | — |
| −1 | K081289 | V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link… | Baxter Healthcare Corp | 2008 | — |
| 0 (this device) | K103551 | Interlink S / Clearlink System / V-Link Lad with Vitalshield Protective… | Baxter Healthcare Corp | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 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? (5)
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 |
|---|---|---|---|
| * | K861557 | Aplicare Skin Protectant Prep PadSummary page 2…880.5090, Product Code NEC), PREDICATE DEVICES: Table 5-2. Previous 510(k)s Device Company Previous Clearance date 510(k) APLICARE Skin Protectant Prep Pad APLICARE, | K861557 July 11, 1986 Modified Interlink Injection Site Septum July 18, 1993 Healthcare Modification to Solution Administration Set | Bax… | 1986 |
| * | K003225 | Solution Administration Sets with Capless Luer Activated ValveSummary page 2…tectant Prep Pad APLICARE, | K861557 July 11, 1986 Modified Interlink Injection Site Septum July 18, 1993 Healthcare Modification to Solution Administration Set | Baxter K003225 October 19, 2000 with Capped Luer Activated Device Healthcare (Clearlink). , CLEARLINK Antimicrobial Luer Activated | Baxter K072… | 2000 |
| * | K072576 | Clearlink Antimicrobial Luer Activated Device (Lad) and Extension Sets with the…Summary page 2…Solution Administration Set | Baxter K003225 October 19, 2000 with Capped Luer Activated Device Healthcare (Clearlink). , CLEARLINK Antimicrobial Luer Activated | Baxter K072576 November 6, 2007 Device and Extension Sets with Healthcare CLEARLINK Antimicrobial Luer Activated Device V-LINK Antimicrobial Lue… | 2007 |
| * | K081289 | V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial…Summary page 2…ated | Baxter K072576 November 6, 2007 Device and Extension Sets with Healthcare CLEARLINK Antimicrobial Luer Activated Device V-LINK Antimicrobial Luer Activated Baxter K081289 August 4, 2008 Device and Extension Sets with V-LINK Healthcare Antimicrobial Luer Activated Device Traditional 5… | 2008 |
| * | — | Modified Interlink Injection Site Septum Named without a submission number |
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 |
|---|---|---|---|---|
| Mar 28, 2013 | Class II | Z-1270-2013 | Packaging process control | Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 3 of the 7 ancestors have a recall of any class.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The IV extension tubing kits provide the user with a “ready-to-use” set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The kits are indicated for one-time use.
The IV extension tubing set is indicated for use with a vascular access device for administration and withdrawal of fluids.
The Vital-Hold catheter stabilization device and the foam tape strips are indicated to provide a method for catheter securement.
The APLICARE skin prep pad is indicated to prepare the skin prior to application of a dressing or bandage.
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/K103551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103551: Interlink S / Clearlink System / V-Link Lad with Vitalshield Protective Coating Non-Dehp Catheter Extension Set Kits,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103551
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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