# K062261: Foam Ring Port Protector

- Pathway: 510(k) (Traditional)
- Applicant: Inspired Ideas, Incorporated
- Decided: Apr 9, 2007 after 248 days
- Product code: OBK (Port, Protector/Cushion)
- Device class: 2
- Regulation: 21 CFR 880.5965
- 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 no predicate by number.

## Indications for use
The foam ring, with the hole in the center, may be used in conjunction with ports (e.g., chemotherapy, vascular, etc.), up to 1 3/8" (3.5 cm) in diameter and raising less than 3/8" above the skin. The device is intended to cushion the localized area surrounding the port.

Source page: https://510kreport.com/device/K062261
Methodology: https://510kreport.com/methodology