# K023206: Sperm Cryoprotec

- Pathway: 510(k) (Traditional)
- Applicant: Nidacon International AB
- Decided: Nov 8, 2002 after 44 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 K991333 (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)
- K991333: Medi-Cult Sperm Freeze Medium, Medicult A/S (2000) Summary page 1.

## Indications for use
The product is intended to be used cryopreservative for protecting human sperm during cryopreservation, an adjunct to one of the techniques for ART (assisted reproductive technology).

Source page: https://510kreport.com/device/K023206
Methodology: https://510kreport.com/methodology