# K921899: Interlink System - T-Connector Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Apr 20, 1993 after 363 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K060074: Interlink System-T-Connector Extension Set, Model 2N3326 (2006), 1 descendant of its own
- K112799: Med-RX Extension Set with T-Connector (2011), 0 descendants of its own
- K970438: Interlink Micro-Infusion Manifold Extension Sets (1997), 0 descendants of its own

## Recalls of this device
- Dec 15, 2005 · Not classified · Z-0630-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0654-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0656-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0643-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0646-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0653-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Oct 17, 2002 · Not classified · Z-0517-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Oct 17, 2002 · Not classified · Z-0518-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.

Source page: https://510kreport.com/device/K921899
Methodology: https://510kreport.com/methodology