# K023769: Prepare Administration Set

- Pathway: 510(k) (Traditional)
- Applicant: Appro Healthcare, Inc.
- Decided: Dec 30, 2002 after 48 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CADDO Administration Set: named in the summary without a submission number

## Indications for use
PrgareTMAdministration Set is intended for the administration of various medical solutions from an IV container to the patient's access catheter and is used only with Deltec O D @ - 1, CADDB-Plus, and CADDO-PCA pumps. Intended for intravenous, intra-arterial, subcutaneous, epidural, and subarachnoid administration. PrepareTh1Administration Set is indicated for use in acute and alternate site settings Alternate sites include, but are not limited to, infusion clinics, nursing homes, and home healthcare.

Source page: https://510kreport.com/device/K023769
Methodology: https://510kreport.com/methodology