# K112413: RI MSC (Migration Sedimentation Chamber)

- Pathway: 510(k) (Traditional)
- Applicant: Research Instruments, Ltd.
- Decided: Jul 13, 2012 after 326 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: 2 generations back to K990941 (1999). 2 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090429: Nunc Ivf Centerwell and Icsi Dishes, Thermo Fisher Scientific (Nalge Nunc Intl) (2009) Summary page 1.

## Most influential descendants
- K133295: Qualis (2014), 5 descendants of its own
- 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

## Indications for use
The RI MVSC is intended to prepare sperm by migration-sedimentation method for the assisted reproduction techniques of intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI).

Source page: https://510kreport.com/device/K112413
Methodology: https://510kreport.com/methodology