# K193015: HydroPICC (PICC-142)

- Pathway: 510(k) (Traditional)
- Applicant: Access Vascular, Inc.
- Decided: Feb 20, 2020 after 114 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K001901 (2000). 43 ancestors in all.
4 later devices descend from it; 3 cite it directly.
2 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172885: HydroPICC, Access Vascular, Inc. (2018) Summary page 4.

## Most influential descendants
- K213550: HydroPICC 5F Dual Lumen Catheter (2022), 2 descendants of its own
- 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
- K243941: HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire  - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire  - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204) (2025), 0 descendants of its own

## Recalls of this device
- Mar 3, 2023 · Class II · Z-1605-2023: The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package.
- Dec 16, 2022 · Class II · Z-1130-2023: Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
- Dec 16, 2022 · Class II · Z-1131-2023: Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
- Feb 24, 2021 · Class II · Z-0199-2023: Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiration date than what is listed on the outer kit package.

## Indications for use
HydroPICC is 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. HydroPICC is rated for a Maximum Power Injection Flow Rate of 3.5mL/sec.

Source page: https://510kreport.com/device/K193015
Methodology: https://510kreport.com/methodology