# K212426: Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])

- Pathway: 510(k) (Traditional)
- Applicant: Donnevie Medical Technology (Shanghai) Co., Ltd.
- Decided: Jun 16, 2022 after 316 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 Reproductive Media consists of Dewin Fertilization Medium (with HSA and without HSA) and Dewin Cleavage Medium (with HSA and without HSA). The indications for use for the Dewin Fertilization Medium and Dewin Cleavage Medium are as follows: Dewin Fertilization Medium is intended for use during in vitro fertilization (IVF) procedures and culture to the two pronuclei (zygote) stage of development. Dewin Fertilization Medium is also intended for washing and handling sperm and collected oocytes after aspiration prior to IVF procedures. Dewin Fertilization Medium is not intended for use in intrauterine insemination procedures. Dewin Cleavage Medium is intended for culture of embryos from the two pronuclei (zygote) stage to the 8-cell stage of embryo development. Dewin Cleavage Medium is also intended for use in the transfer of cleavage stage embryos into the uterine cavity.

Source page: https://510kreport.com/device/K212426
Methodology: https://510kreport.com/methodology