# MQG: Accessory, Assisted Reproduction

- Device class: 2; regulation: 21 CFR 884.6120; FDA's rule: 510(k) required
- FDA decisions: 47
- 510(k) review time 2021–2025: median 261 days (middle half 260–263)
- Recalls: 3 (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)
- 2006: 1
- 2011: 4
- 2012: 1
- 2014: 3
- 2016: 2
- 2017: 2
- 2018: 3
- 2024: 1
- 2025: 1
- 2026: 2

## Most-cited predicates
- K092183: Embryoscope and Embryoslide (2011), cited by 4
- K002805: Kendro Heracell CO2 Incubator (2000), cited by 3
- K173264: EmbryoScope+ (2018), cited by 3
- K983642: Cook Mini-Incubator (1999), cited by 2
- K171736: Geri Embryo Incubator and Geri Dish (2017), cited by 2
- K160753: COOK Vacuum Pump (2017), cited by 2
- K113075: Embryo Viewer Software (2011), cited by 2
- K111715: Embryoscope (2011), cited by 1
- K991263: Thermoplate (1999), cited by 1
- K133712: Embryoviewer Software (2014), cited by 1

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