# K160592: Supercath 6

- Pathway: 510(k) (Traditional)
- Applicant: Togo Medikit Co., Ltd.
- Decided: Aug 12, 2016 after 164 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: 6 generations back to K854773 (1986). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 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.

## Indications for use
The SUPERCATH 6 is intended to access a vein or artery and to administer fluids. The SUPERCATH 6 is designed for single use and for short-term use (less than 30 days), 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/K160592
Methodology: https://510kreport.com/methodology