# K991337: Sperm Maintenance Medium with Glycerol

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Jul 8, 1999 after 80 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K171224: Arctic Sperm Cryopreservation Medium (2017), 0 descendants of its own

## Indications for use
Sperm Maintenance Medium with Glycerol is intended for use in assisted reproductive procedures that involve the manipulation of gametes. Specifically, Sperm Maintenance Medium with Glycerol is intended to be used as a cryopreservation medium for human sperm.

Source page: https://510kreport.com/device/K991337
Methodology: https://510kreport.com/methodology