# K173075: ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)

- Pathway: 510(k) (Abbreviated)
- Applicant: Dxnow, Inc.
- Decided: Mar 8, 2018 after 160 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: 4 generations back to K990941 (1999). 4 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133295: Qualis, Menicon Co., Ltd. New Business Division (2014) Summary page 4.

## Most influential descendants
- K241626: SperSort™ Sperm Sorting Chip (IPG02) (2025), 0 descendants of its own
- K241348: SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) (2025), 0 descendants of its own
- K232980: SpermAlign Sperm Separation Device (2024), 0 descendants of its own
- K221810: LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device (2022), 0 descendants of its own

## Indications for use
The ZyMōt ICSI Sperm Separation Device is intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI) procedures. The ZyMōt Multi Sperm Separation Device is intended for preparing motile sperm 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/K173075
Methodology: https://510kreport.com/methodology