# K212410: VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Vitavitro Biotech Co., Ltd.
- Decided: Feb 1, 2022 after 182 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: 3 generations back to K002383 (2000). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190199: SepaSperm Washing Solution, SepaSperm Solution, Kitazato Corporation (2019) Summary page 4.

## Most influential descendants
- K241095: ARTSMedia Semen Wash Medium (2024), 0 descendants of its own

## Indications for use
VitaVitro® Sperm Washing Medium is intended for preparation and washing of sperm for use in assisted reproduction procedures. VitaVitro® Sperm Washing Medium is also intended for use in intrauterine insemination procedures. VitaVitro® Sperm Gradient Medium is intended for separation of motile sperm from seminal fluid for use in assisted reproduction procedures.

Source page: https://510kreport.com/device/K212410
Methodology: https://510kreport.com/methodology