# K162667: Kitazato IUI Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Kitazato Corporation
- Decided: May 11, 2017 after 227 days
- Product code: MQF (Catheter, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K842231 (1984). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131491: Kitazato Iui Catheter, Kitazato Medical Co., Ltd. (2013) Summary page 5.

## Indications for use
Kitazato IUI Catheter consists of the following versions: • Kitazato IUI Catheter with Outer Stiffener with or without Stylet Cannula, 18 cm, model number Type 4-v1 and Type 4-v2 • Kitazato IUI Catheter with Outer Stiffener with or without Stylet Cannula, 10 cm, model number Type 4-v3 and Type 4-v4 • Kitazato IUI Catheter with Outer Stiffener with Stainless Steel Core, 18 cm, model number Type 5-v1 and Type 5-v2 • Kitazato IUI Catheter with Outer Stiffener with Stainless Steel Core, 10 cm, model number Type 5-v3 and Type 5-v4 Kitazato IUI Catheter is used for the introduction of washed spermatozoa into the uterine cavity through the cervix. Kitazato IUI Stylet is used to provide rigidity and assist in maintaining the shape of the catheter shaft.

Source page: https://510kreport.com/device/K162667
Methodology: https://510kreport.com/methodology