# K983588: Sperm Washing Medium, Modified Sperm Washing Medium

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Apr 26, 1999 after 195 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
- K023222: Isocare One Step Sperm Processing Medium Cat# 2207-12 (2002), 0 descendants of its own

## Indications for use
Sperm Washing Medium and Modified Sperm Washing Medium are intended for assisted reproduction procedures that require the processing or manipulation of human sperm prior to insemination or in vitro fertilization.

Source page: https://510kreport.com/device/K983588
Methodology: https://510kreport.com/methodology