# K241833: V-GRAD

- Pathway: 510(k) (Traditional)
- Applicant: Vitromed GmbH
- Decided: Mar 21, 2025 after 269 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 K991332 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153267: ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash, Origio A/S (2016) Summary page 5.

## Indications for use
V-GRAD is intended for separation of motile sperm from ejaculates by the density gradient method for use in assisted reproduction procedures.

Source page: https://510kreport.com/device/K241833
Methodology: https://510kreport.com/methodology