# K030116: Enhance-S Plus H

- Pathway: 510(k) (Special)
- Applicant: Conception Technology, Inc.
- Decided: Feb 12, 2003 after 30 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
Cell isolation media used for separation and purification of hunian sperm for assisted reproduction procedures.

Source page: https://510kreport.com/device/K030116
Methodology: https://510kreport.com/methodology