# K970438: Interlink Micro-Infusion Manifold Extension Sets

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Apr 2, 1997 after 56 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: 1 generation back to K921899 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921899: Interlink System - T-Connector Extension Set, Baxter Healthcare Corp (1993) Summary page 2.
- (no number) PDI Manifold Extension Sets: named in the summary without a submission number

## Recalls of this device
- Oct 21, 2010 · Not classified · Z-0502-2011: If the manifolds are connected in series, there may be a risk of the manifolds loosening or disconnecting at the luer connection between them.

## Indications for use
Extension Sets with the InterLink® Micro-Infusion Manifold are intended for use with a vascular access device for blood sampling and the administration of multiple drugs and solutions. These devices, like others containing the InterLink® injection site, are designed to reduce the risk of accidental needle sticks when used with the InterLink® cannula, as part of a “needleless” IV access system.

Source page: https://510kreport.com/device/K970438
Methodology: https://510kreport.com/methodology