# K023403: Spermgrad, Models 10022/10063

- Pathway: 510(k) (Traditional)
- Applicant: Vitrolife Sweden AB
- Decided: Dec 13, 2002 after 64 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: 3 generations back to K872849 (1987). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991341: Isolate, Isolate Concentrate, Isolate Stock Solution, Irvine Scientific Sales Co., Inc. (1999) Summary page 1.

## Indications for use
For gradient sperm separation.

Source page: https://510kreport.com/device/K023403
Methodology: https://510kreport.com/methodology