# K200408: VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Vitavitro Biotech Co., Ltd.
- Decided: Oct 16, 2020 after 240 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). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142991: LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA, Life Global Group, LLC (2015) Summary page 4.
- K991395: Quinn's HTF Medium, Quinn's HTF Medium with Hepes, Quinn's Basal XI HTF Medium, Quinn's D3+ HTF Medium, Advanced Reproductive Technologies (2000) Summary page 4.
- 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.

## Most influential descendants
- K251637: Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) (2025), 0 descendants of its own

## Indications for use
VitaVitro® Fertilization Medium is intended for preparation and handling of human gametes and for in vitro fertilization. VitaVitro® Gamete Buffer Medium is intended for human gamete and embryo short-term handling procedures outside the incubator, including washing and intracytoplasmic sperm injection (ICSI). VitaVitro® Flushing Buffer Medium is intended for use during ovarian follicle flushing and oocyte collection procedures for use in in vitro fertilization procedures.

Source page: https://510kreport.com/device/K200408
Methodology: https://510kreport.com/methodology