# K120337: I-Port Advance Injection Port

- Pathway: 510(k) (Abbreviated)
- Applicant: Unomedical A/S
- Decided: Feb 16, 2012 after 13 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K972135 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052389: I-PORT, Patton Medical Devices (2005) Summary page 1.
- K032854: Unomedical Monica Infusion Set, Unomedical A/S (2003) Summary page 1.

## Indications for use
The i-port Advance™ injection port is indicated for patients who administer, or to whom is administered, multiple daily subcutaneous injections of physician prescribed medications, including insulin. The device may remain in place for up to 72 hours to accommodate multiple drug injections without the discomfort of additional needle sticks. The i-port Advance™ may be used on a wide range of patients, including adults and children. Model numbers for the device include 020110, 020210, 020102 and 020202.

Source page: https://510kreport.com/device/K120337
Methodology: https://510kreport.com/methodology