# K033301: IV Administration and Connect Sets

- Pathway: 510(k) (Traditional)
- Applicant: Codan US Corp.
- Decided: Mar 4, 2004 after 142 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
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 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
- K112314: Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter (2012), 5 descendants of its own
- K231534: 5008X Hemodialysis System (2024), 2 descendants of its own
- K243505: 5008X Hemodialysis System (2025), 1 descendant of its own
- K210575: HDF Assist Mudule, HDF Infusion Set and Substitution Filter (2022), 1 descendant of its own
- K251851: DIASAFEplusUS (F00013010) (2025), 0 descendants of its own

## Recalls of this device
- Sep 12, 2019 · Class II · Z-2433-2020: Individual packages of connectors may have incomplete or bad seals which would compromise sterility.

## Indications for use
The CODAN IVAdministration sets, In-line sets and Connect Sets are indicated for use 1.o facilitate the continuous and bolus infusion of IVfluids, pain control medications, chemotherapeutic drugs and pharmaceuticals into patient vascular systems.

Source page: https://510kreport.com/device/K033301
Methodology: https://510kreport.com/methodology