# K192540: Kitazato ET Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Kitazato Corporation
- Decided: May 1, 2020 after 228 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: 2 generations back to K983594 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173686: Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter, Cook Incorporated (2018) Summary page 5.

## Indications for use
Kitazato ET Catheters are intended for ultrasound guided introduction of embryos into the uterine cavity following in vitro fertilization.

Source page: https://510kreport.com/device/K192540
Methodology: https://510kreport.com/methodology