# K072230: Powerpicc Solo

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Oct 5, 2007 after 56 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: 8 generations back to K001901 (2000). 27 ancestors in all.
5 later devices descend from it; 4 cite it directly.
3 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033389: Powerpicc Catheters, Models 3175155, 3175135, C.R. Bard, Inc. (2004) Summary page 1.
- K050931: 6 FR DL Powerpicc Catheter, C.R. Bard, Inc. (2005) Summary page 1.
- K051672: Powerpicc, Bard Access Systems, Inc. (2005) Summary page 1.
- K053501: Powerpicc, Bard Access Systems, Inc. (2006) Summary page 1.
- K070996: 4 FR Single Lumen (SL) Powerpicc Catheter, C.R. Bard, Inc. (2007) Summary page 1.
- K051991: Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line, C.R. Bard, Inc. (2005) Summary page 1.
- K063848: Powergroshong Picc Catheter, C.R. Bard, Inc. (2007) Summary page 1.
- K021704: Vaxcel Picc with Pasv Valve Technology, Catheter Innovations, Inc. (2002) Summary page 2.

## Most influential descendants
- K151985: PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter (2016), 1 descendant of its own
- K210264: BD PowerPiCC Catheter (2021), 0 descendants of its own
- K181904: 5 FR Dual Lumen Piper PICC (2018), 0 descendants of its own
- K141633: Pro-Picc with Valve Technology (2014), 0 descendants of its own
- K130897: Medcomp Vascu-Picc with Valve (2013), 0 descendants of its own

## Recalls of this device
- May 27, 2015 · Class III · Z-2049-2015: Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.
- May 27, 2015 · Class III · Z-2048-2015: Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.
- May 27, 2015 · Class III · Z-2047-2015: Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.
- May 27, 2015 · Class III · Z-2050-2015: Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.

## Indications for use
The PowerPICC SOLOTM catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media and allows for central venous pressure monitoring. 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. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

Source page: https://510kreport.com/device/K072230
Methodology: https://510kreport.com/methodology