# K052267: Supercath V

- Pathway: 510(k) (Traditional)
- Applicant: Togo Medikit Co., Ltd.
- Decided: Oct 27, 2006 after 434 days
- Product code: FIE (Needle, Fistula)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K854773 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K854773: Supercath a.V. Fistula, Togo Medikit Co., Ltd. (1986) Summary page 1.
- K050114: Supercath Z3V, Togo Medikit Co., Ltd. (2005) Summary page 1.

## Indications for use
The Supercath V fistula catheter is intended to access a vein or artery while connected to a blood circuit during kidney dialysis. The Supercath V is intended to minimize inadvertent needlestieks or is intended to reduce accidental needlesticks.

Source page: https://510kreport.com/device/K052267
Methodology: https://510kreport.com/methodology