# K200249: Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])

- Pathway: 510(k) (Traditional)
- Applicant: Kitazato Corporation
- Decided: Oct 23, 2020 after 263 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 5.

## Indications for use
Sequential Culture Media consists of Fertilization Medium, Cleavage Medium, and Blastocyst Medium that are intended to be used sequentially from fertilization to the blastocyst stage of development. The intended uses of the Fertilization Medium, Cleavage Medium, and Blastocyst Medium are as follows: Fertilization medium is intended for use during in vitro fertilization (IVF) and intracytoplasmic sperm insertion (ICSI) procedures and culture to the two pronuclei (zygote) stage of development. Cleavage Medium is intended for culture of embryos from the two pronuclei (zygote) stage to the 8-cell stage of development. Cleavage Medium is not intended for transferring embryos to the uterine cavity Blastocyst Medium is intended for culture from the 8-cell stage to the blastocyst stage of development. Blastocyst Medium is not intended for transferring embryos to the uterine cavity

Source page: https://510kreport.com/device/K200249
Methodology: https://510kreport.com/methodology