# K242043: Sperm Freezing Medium

- Pathway: 510(k) (Traditional)
- Applicant: Gimbo Medical Technology Shenzhen Co., Ltd.
- Decided: Jan 8, 2025 after 180 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Sperm Freezing Medium is intended for the cryopreservation of human semen samples to prevent damage to sperm samples during cryopreservation and thawing prior to use in assisted reproductive technology procedures.

Source page: https://510kreport.com/device/K242043
Methodology: https://510kreport.com/methodology