# K811463: Auto-Syringe Micro Volume Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jun 12, 1981 after 17 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 4 (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; 1 cites it directly.
1 of 4 devices in its family (counting itself) has 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
- K974013: Extension Set with Microbore Tubing, Extension Set with Microbore Tubing and 0.2 U Filter, Extension Set with Microbore (1997), 2 descendants of its own
- K162219: CADD® Infusion Disposables Portfolio with NRFit™ connectors (2017), 1 descendant of its own
- K211649: PCEA Syringe Set (2021), 0 descendants of its own

## Recalls of this device
- Dec 15, 2005 · Not classified · Z-0632-06: 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-0633-06: 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-0631-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Jul 16, 2003 · Not classified · Z-1151-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.

Source page: https://510kreport.com/device/K811463
Methodology: https://510kreport.com/methodology