# K993463: Intravascular Administration Set

- Pathway: 510(k) (Traditional)
- Applicant: Custom Assemblies, Inc.
- Decided: Jan 4, 2000 after 83 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 K940319 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940319: R-Group International Coiled Low Pressure Extension Line, R-Group Intl. (1994) Summary page 1.
- K991932: Intravascular Administration Set, The Kipp Group (1999) Summary page 1.

## Recalls of this device
- Oct 28, 2021 · Class II · Z-0400-2022: This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the sterile version of the same Intravascular 

## Indications for use
Indicated as a single use, sterile device for use in I.V. therapy when an extended fluid path is required for administration.

Source page: https://510kreport.com/device/K993463
Methodology: https://510kreport.com/methodology