# K190199: SepaSperm Washing Solution, SepaSperm Solution

- Pathway: 510(k) (Traditional)
- Applicant: Kitazato Corporation
- Decided: Sep 26, 2019 after 234 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 K002383 (2000). 2 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K152782: Sydney Ivf Sperm Medium, Sydney Ivf Sperm Gradient Kit, Sydney Ivf Spermient, William A. Cook Australia Pty., Ltd. (2015) Summary page 4.

## Most influential descendants
- K212410: VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium (2022), 1 descendant of its own
- K241095: ARTSMedia Semen Wash Medium (2024), 0 descendants of its own
- K192644: GM501 SpermAir and GM501 SpermActive (2020), 0 descendants of its own

## Indications for use
SepaSperm Washing Solution is used for preparation and washing of sperm for use in assisted reproduction procedures. SepaSperm Washing Solution is not intended for use in intrauterine insemination procedures. SepaSperm Solution is used for separation of motile sperm from seminal fluid for use in assisted reproduction procedures.

Source page: https://510kreport.com/device/K190199
Methodology: https://510kreport.com/methodology