# K003682: Medcomp Z-Cath

- Pathway: 510(k) (Traditional)
- Applicant: Medical Components, Inc.
- Decided: Jan 26, 2001 after 57 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
No predicates in its family tree.
14 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K091586: Vascu-Picc and Midline Catheters, Single, Double and Triple Lumen (2009), 9 descendants of its own
- K063363: Firmgrip Peripherally Inserted Catheter Device (2007), 3 descendants of its own
- K123292: T3 (2013), 2 descendants of its own
- K130034: Uni-Picc (2013), 2 descendants of its own
- K080793: Firmgrip (2008), 2 descendants of its own

## Recalls of this device
- Sep 15, 2005 · Not classified · Z-0104-06: The product is labelled as containing a 4F catheter when the trays/kits actually contain a 5F catheter. The catheters will not fit into the sheath-dilator that was included in the tray. mislabeled as 
- Sep 15, 2005 · Not classified · Z-0103-06: The product is labelled as containing a 4F catheter when the trays/kits actually contain a 5F catheter. The catheters will not fit into the sheath-dilator that was included in the tray. mislabeled as 

Source page: https://510kreport.com/device/K003682
Methodology: https://510kreport.com/methodology