# K223669: SecurePortIV Advanced Catheter Securement Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Adhezion Biomedical, LLC
- Decided: Jun 12, 2023 after 187 days
- Product code: NZP (Sealant, Microbial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- 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 K083354 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170505: SecurePortIV Catheter Securement Adhesive, Adhezion Biomedical, LLC (2017) Summary page 4.

## Indications for use
SECUREPORTIV® ADVANCED Catheter Securement Adhesive is to be applied as a film forming securement and sealant at the point of vascular access catheter skin entry. The film holds the catheter to the skin to reduce catheter movement, migration, and/or dislodgment. It is used to protect the catheter skin entry site by creating a sealant that immobilizes surface bacteria, preventing them from entering into the catheter skin entry site while also providing a moisture barrier. SECUREPORTIV® ADVANCED is intended to be used with a transparent film dressing for the securement of short-term and long-term vascular access catheters including peripheral IVs, PICCs, and CVCs.

Source page: https://510kreport.com/device/K223669
Methodology: https://510kreport.com/methodology