# K152782: Sydney Ivf Sperm Medium, Sydney Ivf Sperm Gradient Kit, Sydney Ivf Spermient

- Pathway: 510(k) (Special)
- Applicant: William A. Cook Australia Pty., Ltd.
- Decided: Dec 21, 2015 after 87 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: 1 generation back to K002383 (2000). 1 ancestor in all.
4 later devices descend 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)
- K002383: Cook Ivf Sperm Buffer, Cook Ivf Sperm Medium, and Cook Ivf Sperm Gradient Kit, Cook Ob/Gyn (2000) Summary page 6.

## Most influential descendants
- K190199: SepaSperm Washing Solution, SepaSperm Solution (2019), 3 descendants of its own
- 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
Sydney IVF Sperm Medium is intended for use during in vitro fertilization procedures to process sperm. Sydney IVF Sperm Gradient Kit is intended for use during in vitro fertilization procedures to separate motile sperm from seminal plasma. Sydney IVF Spermient is intended for use during in vitro fertilization procedures to separate motile sperm from seminal plasma.

Source page: https://510kreport.com/device/K152782
Methodology: https://510kreport.com/methodology