# K061145: Spermslow

- Pathway: 510(k) (Traditional)
- Applicant: Medicult A/S
- Decided: Oct 2, 2006 after 160 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 K991329 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991329: Medi-Cult PVP Medium, Medi-Cult PVP Clinical Grade, Medicult A/S (2000) Summary page 1.

## Indications for use
SpermSlow TM is used to slow down the movement of sperm to allow for the selection of the most mature, viable sperm for Intracytoplasmic sperm injection (ICSI).

Source page: https://510kreport.com/device/K061145
Methodology: https://510kreport.com/methodology