# K220010: Daylily Single Use Sterile Embryo Transfer Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Horizon Medical Technology Co., Ltd.
- Decided: Dec 16, 2022 after 346 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)
- K172051: Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter, Cook Incorporated (2018) Summary page 4.

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

Source page: https://510kreport.com/device/K220010
Methodology: https://510kreport.com/methodology