# K991932: Intravascular Administration Set

- Pathway: 510(k) (Traditional)
- Applicant: The Kipp Group
- Decided: Aug 20, 1999 after 73 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.
21 later devices descend from it; 3 cite it directly.
0 of 22 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
- K051499: Intravascular Administration Set and Extension Set (2005), 18 descendants of its own
- K140831: Maxzero Extension Set with Needless Connector (2014), 13 descendants of its own
- K162804: Q2 Low Pressure Power Injection Extension Set (2017), 4 descendants of its own
- K182897: Velano Vascular Q2 Extension Set (2019), 3 descendants of its own
- K153293: Extension Set (2016), 3 descendants of its own

## Recalls of this device
- Jun 9, 2003 · Not classified · Z-0956-03: The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
- May 13, 2003 · Not classified · Z-0914-03: IV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced.

## Indications for use
Intravascular Administration Set and Extension Set is a device used to serve as a conduit for delivery of L.V. fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. Additional indications for use of this device is to provide multiple secondary sterile injection sites for other infusion fluids. The device may include a drip chamber with a hollow spike to penetrate and connect the tubing to an LV. bag or other infusion fluid container, an infusiorr line filter, a 2 or 3 port manifold or LV. set stopcock, fluid delivery tubing, connectors between parts of the set, a Y-site injection site, a PRN injection site, a Y-site with integral check valve, a Spin-Loc connector and one or more Roller/Slide/Pinch clamps.

Source page: https://510kreport.com/device/K991932
Methodology: https://510kreport.com/methodology