# K210264: BD PowerPiCC Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Bard Access Systems, Inc.
- Decided: Jul 30, 2021 after 179 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 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K001901 (2000). 28 ancestors in all.
No later device cites it as a predicate yet.
3 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072230: Powerpicc Solo, C.R. Bard, Inc. (2007) Summary page 4.

## Recalls of this device
- May 21, 2026 · Class II · Z-2666-2026: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
- Mar 11, 2025 · Class I · Z-1507-2025: Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, w

## Indications for use
The PowerPICC Catheter is indicated for short or long- term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. The maximum infusion flow rate is SmL/second for power injection of contrast media. For central venous pressure monitoring, it is recommended that a catheter lumen of 20gauge or larger be used.

Source page: https://510kreport.com/device/K210264
Methodology: https://510kreport.com/methodology