# K112396: Iui Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Kitazato Medical Co., Ltd.
- Decided: Nov 2, 2012 after 441 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: 1 generation back to K013501 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013501: Iui, Model 4220; Smooze, Model 4225, L; Seminor, Model 4502 a, B, Gynetics Medical Products NV (2001) Summary page 2.

## Indications for use
Kitazato IUI Catheters consist of the following versions: * Kitazato IUI Catheter with Stainless Steel Core Type, 10 cm, model number Type 1-vi * Kitazato IUI Catheter with Stainless Steel Core Type, 7 cm, model number Type 1-v2 * Kitazato IUI Catheter without Stainless Steel Core Type, 10 cm, model number Type 2-vi * Kitazato IUI Catheter without Stainless Steel Core Type, 7 cm, model number Type 2-v2 Kitazato IUI Catheters are used for the introduction of washed spermatozoa into the uterine cavity through the cervix.

Source page: https://510kreport.com/device/K112396
Methodology: https://510kreport.com/methodology