# K991332: Medi-Cult Sperm Preparation - Medium;

- Pathway: 510(k) (Traditional)
- Applicant: Medicult A/S
- Decided: May 4, 2000 after 381 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K153267: ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash (2016), 1 descendant of its own
- K241833: V-GRAD (2025), 0 descendants of its own

## Indications for use
The intended use of Medi-Cult Sperm Preparation Medium is for sperm washing and for sperm separation by swim-up method, since seminal plasma must be separated from the spermatozoa in order to facilitate capacitation. The selection of motil spermatozoa is done in order to increase the likelihood of fertilization. The Sperm Preparation Medium is also used as holding medium for the oocytes before ICSI.

Source page: https://510kreport.com/device/K991332
Methodology: https://510kreport.com/methodology