# K232980: SpermAlign Sperm Separation Device

- Pathway: 510(k) (Traditional)
- Applicant: Cytoswim, Ltd.
- Decided: Mar 14, 2024 after 175 days
- Product code: MQK (Labware, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K990941 (1999). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173075: ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml), Dxnow, Inc. (2018) Summary page 5.

## Indications for use
The SpermAlign Sperm Separation Device is intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI) and in vitro fertilization (IVF) procedures.

Source page: https://510kreport.com/device/K232980
Methodology: https://510kreport.com/methodology