# MQK: Labware, Assisted Reproduction

- Device class: 2; regulation: 21 CFR 884.6160; FDA's rule: 510(k) required
- FDA decisions: 51
- 510(k) review time 2021–2025: median 170 days (middle half 143–237)
- Recalls: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2016: 2
- 2017: 2
- 2018: 4
- 2019: 1
- 2020: 2
- 2021: 1
- 2022: 2
- 2024: 4
- 2025: 3
- 2026: 1

## Most-cited predicates
- K173075: ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) (2018), cited by 4
- K090832: Rapid-I (2009), cited by 3
- K122982: Cryolock (2014), cited by 3
- K993881: Genx Culture Dish (2000), cited by 2
- K153027: Cryotop US (2016), cited by 2
- K112413: RI MSC (Migration Sedimentation Chamber) (2012), cited by 2
- K200815: VitriGuard (2020), cited by 2
- K092398: HSV Straw (2010), cited by 2
- K090429: Nunc Ivf Centerwell and Icsi Dishes (2009), cited by 2
- K040717: Nunc Ivf Multidish 4 Wells Nunclon (2004), cited by 2

Source page: https://510kreport.com/product-code/MQK
Data by year (CSV): https://510kreport.com/product-code/MQK.csv