# K231370: Dewin Blastocyst Medium (with HSA and without HSA)

- Pathway: 510(k) (Traditional)
- Applicant: Donnevie Medical Technology (Shanghai) Co., Ltd.
- Decided: Aug 4, 2023 after 84 days
- Product code: MQL (Media, Reproductive)
- Device class: 2
- Regulation: 21 CFR 884.6180
- 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 K002385 (2000). 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)
- K153290: Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium, William A. Cook Australia Pty., Ltd. (2016) Summary page 4.

## Indications for use
Dewin Blastocyst Medium (with HSA and without HSA) is intended for culture from the 8-cell stage to the blastocyst stage of embryo development. Dewin Blastocyst Medium (with HSA and without HSA) is also intended for use in transfer of blastocyst stage embryos into the uterine cavity.

Source page: https://510kreport.com/device/K231370
Methodology: https://510kreport.com/methodology