# K091953: Pro-Picc

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: Sep 16, 2009 after 77 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K001901 (2000). 24 ancestors in all.
29 later devices descend from it; 8 cite it directly.
2 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053345: Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6D, Medcomp (2006) Summary page 1.
- K081904: Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray), Medcomp (2008) Summary page 1.
- K070996: 4 FR Single Lumen (SL) Powerpicc Catheter, C.R. Bard, Inc. (2007) Summary page 1.

## Most influential descendants
- K141151: CT Midline (2014), 8 descendants of its own
- K093309: Pro-Line CT (Basic Tray) Model MR28036101 (2009), 8 descendants of its own
- K101329: Synergy CT Picc (2010), 6 descendants of its own
- K153393: PowerMidline Catheter (2016), 5 descendants of its own
- K113487: Hemo-Cath 10F, Hemo-Cath 12.5F (2012), 3 descendants of its own

## Indications for use
The PRO-PICC® catheter is indicated for short term or long term peripheral access to the central-venous system for intravenous therapy and power injection of contrast media and allows for central venous pressure monitoring when a 20gauge or larger lumen is used. For blood sampling, infusion or therapies use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

Source page: https://510kreport.com/device/K091953
Methodology: https://510kreport.com/methodology