# K253354: Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Hehong Biotech Co., Ltd.
- Decided: Feb 12, 2026 after 135 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: 3 generations back to K983594 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162878: Kitazato ET Catheters, Kitazato Corporation (2017) Summary page 5.

## Indications for use
Minvitro Embryo Transfer Catheters are used to place in vitro fertilized (IVF) embryos into the uterine cavity.

Source page: https://510kreport.com/device/K253354
Methodology: https://510kreport.com/methodology