# K131491: Kitazato Iui Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Kitazato Medical Co., Ltd.
- Decided: Sep 11, 2013 after 111 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: 4 generations back to K842231 (1984). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061679: Wallace Artificial Insemination Catheter, Irvine Scientific Sales Co., Inc. (2006) Summary page 1.

## Most influential descendants
- K162667: Kitazato IUI Catheter (2017), 0 descendants of its own

## Indications for use
Kitazato IUI Catheter consist of the following versions: Kitazato IUI Catheter with Outer Stiffener with Stylet Cannula, 18 cm, model number Type 3-v1 Kitazato IUI Catheter with Outer Stiffener without Stylet Cannula, 18 cm, model number Type 3-v2 Kitazato IUI Catheter is used for the introduction of washed spermatozoa into the uterine cavity through the cervix.

Source page: https://510kreport.com/device/K131491
Methodology: https://510kreport.com/methodology