# K052389: I-PORT

- Pathway: 510(k) (Abbreviated)
- Applicant: Patton Medical Devices
- Decided: Sep 9, 2005 after 9 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: 1 generation back to K881767 (1988). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881767: Viggo Insuflon, Ohmeda Medical (1988) Summary page 1.
- K030149: Medtronic Minimed Sof-Site Infusion Set, Models MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, and MMT-359L9, Avail Medical Products, Inc. (2003) Summary page 1.

## Most influential descendants
- K120337: I-Port Advance Injection Port (2012), 0 descendants of its own

## Indications for use
The I-PORTTM, Injection Port is indicated for patients who administer, or to whom is administered, multiple daily subcutaneous injections of physician prescribed medications, including insulin. The I-PORT TM, Injection Port may remain in place for up to 72 hours to accommodate multiple drug injections without the discomfort of additional needle sticks. This device may be used on a wide range of patients, including adults and children.

Source page: https://510kreport.com/device/K052389
Methodology: https://510kreport.com/methodology