# K051672: Powerpicc

- Pathway: 510(k) (Traditional)
- Applicant: Bard Access Systems, Inc.
- Decided: Nov 23, 2005 after 153 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K001901 (2000). 6 ancestors in all.
178 later devices descend from it; 9 cite it directly.
14 of 185 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050931: 6 FR DL Powerpicc Catheter, C.R. Bard, Inc. (2005) Summary page 1.

## Most influential descendants
- K053501: Powerpicc (2006), 108 descendants of its own
- K070996: 4 FR Single Lumen (SL) Powerpicc Catheter (2007), 66 descendants of its own
- K060812: Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple (2006), 66 descendants of its own
- K081904: Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray) (2008), 31 descendants of its own
- K091953: Pro-Picc (2009), 29 descendants of its own

## Recalls of this device
- May 19, 2021 · Class II · Z-1991-2021: Catheter kits contained the incorrect micro-introducers.

## Indications for use
The PowerPICC® catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. The maximum pressure of power injectors used with the PowerPICC catheter may not exceed 300 psi.

Source page: https://510kreport.com/device/K051672
Methodology: https://510kreport.com/methodology