# K002383: Cook Ivf Sperm Buffer, Cook Ivf Sperm Medium, and Cook Ivf Sperm Gradient Kit

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ob/Gyn
- Decided: Sep 13, 2000 after 40 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
No predicates in its family tree.
5 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K152782: Sydney Ivf Sperm Medium, Sydney Ivf Sperm Gradient Kit, Sydney Ivf Spermient (2015), 4 descendants of its own
- 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

Source page: https://510kreport.com/device/K002383
Methodology: https://510kreport.com/methodology