# K241348: SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)

- Pathway: 510(k) (Traditional)
- Applicant: Motilitycount Aps
- Decided: Jan 31, 2025 after 263 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 SwimCount® Harvester is intended for preparing motile sperm cells from semen for use in the treatment of infertile couples by Intracytoplasmic Sperm Injection (ICSI), In Vitro Fertilization (IVF) and Intrauterine Insemination (IUI) procedures.

Source page: https://510kreport.com/device/K241348
Methodology: https://510kreport.com/methodology