# K081904: Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray)

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: Sep 23, 2008 after 82 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 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001901 (2000). 13 ancestors in all.
31 later devices descend from it; 2 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053501: Powerpicc, Bard Access Systems, Inc. (2006) Summary page 1.
- K053345: Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6D, Medcomp (2006) Summary page 1.

## Most influential descendants
- K091953: Pro-Picc (2009), 29 descendants of its own
- 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

## Recalls of this device
- Dec 17, 2012 · Class II · Z-0937-2013: Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.
- Dec 13, 2012 · Class II · Z-0898-2013: The affected product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.

## Indications for use
The PRO-PICC TM IT 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. 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/K081904
Methodology: https://510kreport.com/methodology