# K190001: Supercath 5

- Pathway: 510(k) (Traditional)
- Applicant: Togo Medikit Co., Ltd.
- Decided: Sep 20, 2019 after 261 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: 7 generations back to K854773 (1986). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140419: SUPERCATH5, Togo Medikit Co., Ltd. (2014) Summary page 5.
- K172496: Supercath 5 (26G), Togo Medikit Co., Ltd. (2018) Summary page 5.

## Indications for use
The Supercath 5 is intended to access a vein or artery and to administer fluids and/or blood. The Supercath 5 is designed for single use, and is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks. The 18 - 22 gauge catheters may be used with power injectors at a maximum pressure of 300 psi.

Source page: https://510kreport.com/device/K190001
Methodology: https://510kreport.com/methodology