# K023890: Prepare Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Appro Healthcare, Inc.
- Decided: Feb 7, 2003 after 78 days
- Product code: MRZ (Accessories, Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- 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) CADDB Medication Cassette Reservoir: named in the summary without a submission number
- (no number) CADDB Administration Set: named in the summary without a submission number

## Indications for use
PrepareTMCartridge is used as a drug reservoir and fluid path for administering intravenous, intra-arterial, subcutaneous, epidural, and subarachnoid drugs to a patient's access site using specified infusion pumps and extension sets. For intravenous, intra-arterial, subcutaneous, epidural and subarachnoid administration PrepareTMCartridge must be used only with SIMS Deltec CADDB-1, CADDB-Plus, and CADDB-PCA pumps for the infusion of various medicinal solutions. PrepareTMCartridge is indicated for use in acute and alternate care settings. Alternate care includes, but is not limited to, infusion clinics, nursing homes, and home healthcare.

Source page: https://510kreport.com/device/K023890
Methodology: https://510kreport.com/methodology