# K030117: Enhance Sperm Freeze

- Pathway: 510(k) (Traditional)
- Applicant: Conception Technology, Inc.
- Decided: Mar 20, 2003 after 66 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K053494: Oil for Tissue Culture, Gradient System and Spermfreeze (2006), 1 descendant of its own
- K191552: GM501 Mineral Oil (2019), 0 descendants of its own
- K043494: Mastel Laser Clean Room, Model Ebs-100 (2005), 0 descendants of its own

## Indications for use
Sperm Freeze is intended to be used as a cryopreservation medium for human sperm.

Source page: https://510kreport.com/device/K030117
Methodology: https://510kreport.com/methodology