# K230718: UTC 3mL Medication Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Gilero, LLC
- Decided: Jun 15, 2023 after 92 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
Longest line of descent: 1 generation back to K051568 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051568: Cadd-MS 3 Ambulatory Infusion Pump, Smiths Medical MD, Inc. (2005) Summary page 5.

## Indications for use
The UTC 3 ml Medication Cartridge is intended for use in hospital and outpatient care environments with the CADD-MS® 3 Ambulatory Infusion Pump for subcutaneous infusion of medication in adults.

Source page: https://510kreport.com/device/K230718
Methodology: https://510kreport.com/methodology