# K103551: Interlink S / Clearlink System / V-Link Lad with Vitalshield Protective Coating Non-Dehp Catheter Extension Set Kits,

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Mar 25, 2011 after 113 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K915571 (1992). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861557: Aplicare Skin Protectant Prep Pad, Aplicare, Inc. (1986) Summary page 2.
- K003225: Solution Administration Sets with Capless Luer Activated Valve, Baxter Healthcare Corp (2000) Summary page 2.
- K072576: Clearlink Antimicrobial Luer Activated Device (Lad) and Extension Sets with the Clearlink Antimicrobial Luer Activated, Baxter Healthcare Corp (2007) Summary page 2.
- K081289: V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial Luer Activated Device, Baxter Healthcare Corp (2008) Summary page 2.
- (no number) Modified Interlink Injection Site Septum: named in the summary without a submission number

## Recalls of this device
- Mar 28, 2013 · Class II · Z-1270-2013: Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.

## Indications for use
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.

Source page: https://510kreport.com/device/K103551
Methodology: https://510kreport.com/methodology