# K133295: Qualis

- Pathway: 510(k) (Traditional)
- Applicant: Menicon Co., Ltd. New Business Division
- Decided: Jun 18, 2014 after 236 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: 3 generations back to K990941 (1999). 3 ancestors in all.
5 later devices descend from it; 1 cites 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)
- K112413: RI MSC (Migration Sedimentation Chamber), Research Instruments, Ltd. (2012) Summary page 1.

## Most influential descendants
- K173075: ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) (2018), 4 descendants of its own
- 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 Quais is intended for preparing motile human sperm for use in the treatment of infertile couples by intracytoplasmic sperm insertion (ICSI) fertilization.

Source page: https://510kreport.com/device/K133295
Methodology: https://510kreport.com/methodology