# K213550: HydroPICC 5F Dual Lumen Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Access Vascular, Inc.
- Decided: May 4, 2022 after 177 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K001901 (2000). 44 ancestors in all.
2 later devices descend from it; 2 cite it directly.
2 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193015: HydroPICC (PICC-142), Access Vascular, Inc. (2020) Summary page 4.

## Most influential descendants
- K243458: HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr (2025), 0 descendants of its own
- K251212: Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM)  (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) (2025), 0 descendants of its own

## Recalls of this device
- Aug 31, 2023 · Class II · Z-0115-2024: Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen C
- Aug 31, 2023 · Class II · Z-0114-2024: Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen C

## Indications for use
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 3.5ml/s

Source page: https://510kreport.com/device/K213550
Methodology: https://510kreport.com/methodology