# K130034: Uni-Picc

- Pathway: 510(k) (Traditional)
- Applicant: Health Line International Corporation
- Decided: Mar 8, 2013 after 60 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: 11 generations back to K001901 (2000). 39 ancestors in all.
2 later devices descend from it; 1 cites it directly.
2 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101329: Synergy CT Picc, Health Line International Corporation (2010) Summary page 3.
- K102966: 2.6F X 20CM Vascu-Picc, 2.6F X 50CM Vascu-Picc, Medcomp (2010) Summary page 3.
- K091586: Vascu-Picc and Midline Catheters, Single, Double and Triple Lumen, Medcomp (2009) Summary page 2.

## Most influential descendants
- K140270: Nexus Midline CT Catheter (2014), 1 descendant of its own
- K200263: Health Line CT Midline Catheter (2020), 0 descendants of its own

## Indications for use
The UNI-PICCm' Peripherally Inserted Central Catheter is indicated for short or long term access to the central venous system for intravenous administration of fluids, medications and/or nutritional therapy when prescribed. Blood sampling may also be conducted with UNI-PJCCmt The 3F UNI-PICC m Peripherally inserted Central Catheter is indicated for short or long term access to the central venous system via peripheral insertion in neonates, infants and children. It may be used for administration of fluids, medications and/or nutritional therapy when prescribed.

Source page: https://510kreport.com/device/K130034
Methodology: https://510kreport.com/methodology