# K980992: IV Administration Sets with Needleless Access Devices

- Pathway: 510(k) (Traditional)
- Applicant: Venetec Intl., Inc.
- Decided: May 28, 1998 after 72 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 2 (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’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K090134: Intravenous Power Injector Extension Set (2009), 1 descendant of its own
- K102405: Infusion Set for Powerpicc Solo 2 Catheter (2011), 0 descendants of its own
- K093489: IN Vision-Plus Nano with Neutral Advantage Technology (2010), 0 descendants of its own

## Recalls of this device
- Apr 2, 2009 · Not classified · Z-1539-2009: The affected units may contain extension sets with the microbore tubing instead of extension sets with the macrobore tubing.
- May 12, 2003 · Not classified · Z-0925-03: Set tubing disconnected from the male luer lock during use on patients. Misassembled.

## Indications for use
An extension set to be used as an extension to the Intravascular administration set used for fluid delivery. The IV extension set will connect the IV administration set to a catheter or needle inserted into a vessel. The IV extension set contains needleless access devices to protect the users from needle stick injuries.

Source page: https://510kreport.com/device/K980992
Methodology: https://510kreport.com/methodology