# K050114: Supercath Z3V

- Pathway: 510(k) (Traditional)
- Applicant: Togo Medikit Co., Ltd.
- Decided: Jun 9, 2005 after 142 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K854773 (1986). 3 ancestors in all.
30 later devices descend from it; 3 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030571: Acuvance Plus Safety IV Catheter, Protectiv Plus Safety IV Catheter, Optiva IV Catheter, Ethicon Endo-Surgery, Inc. (2003) Summary page 1.
- K864038: Supercath I.V. Catheter, Togo Medikit Co., Ltd. (1986) Summary page 1.
- K854773: Supercath a.V. Fistula, Togo Medikit Co., Ltd. (1986) Summary page 1.

## Most influential descendants
- K081953: Supercath 5 (2009), 28 descendants of its own
- K093546: Supercath 5 Model SP120-XX-XX, SP125-XX-XX (2009), 27 descendants of its own
- K110443: BD Insyte Autoguard BC (2011), 21 descendants of its own
- K140504: Accucath BC Intravascular Catheter System (2014), 7 descendants of its own
- K153298: AccuCath Intravascular Catheter (2015), 5 descendants of its own

## Indications for use
The SUPERCATH Z3V intravascular catheter is intended to access vein or artery and to administer fluids. The SUPERCATH Z3V is designed for short-term use (less than 30 days), is intended to minimize inadvertent needlesticks or is intended to reduce accidental needlesticks.

Source page: https://510kreport.com/device/K050114
Methodology: https://510kreport.com/methodology