# K251212: Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM)  (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)

- Pathway: 510(k) (Special)
- Applicant: Access Vascular, Inc.
- Decided: Jul 1, 2025 after 74 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K001901 (2000). 45 ancestors in all.
No later device cites it as a predicate yet.
2 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213550: HydroPICC 5F Dual Lumen Catheter, Access Vascular, Inc. (2022) Summary page 5.

## Indications for use
Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM): Indicated for short-or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for maximum power injection flow rate of 4.0ml/s. Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM): Indicated for short-or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for maximum power injection flow rate of 5.0ml/s.

Source page: https://510kreport.com/device/K251212
Methodology: https://510kreport.com/methodology