# MQL: Media, Reproductive

- Device class: 2; regulation: 21 CFR 884.6180; FDA's rule: 510(k) required
- FDA decisions: 260
- 510(k) review time 2021–2025: median 227 days (middle half 148–263)
- Recalls: 6 (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)
- 2017: 10
- 2018: 4
- 2019: 6
- 2020: 8
- 2021: 1
- 2022: 3
- 2023: 5
- 2024: 12
- 2025: 9
- 2026: 3

## Most-cited predicates
- K060168: Vitrification Freeze Kit, Vitrification Thaw Kit (2006), cited by 7
- K171748: Vitrification Kit and Thawing Kit (2017), cited by 6
- K153290: Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium (2016), cited by 5
- K160006: Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit (2016), cited by 4
- K983586: HTF Medium, Modified HTF Medium- Hepes, HTF Powder (Without Antibiotics), Modified HTG Powder- Hepes (Without Antiboditi (1999), cited by 3
- K080446: Rapidvit and Rapidwarm Cleave (2008), cited by 3
- K133568: G-TL (2014), cited by 3
- K142991: LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA (2015), cited by 3
- K121572: Continuous Single Culture Complete (2012), cited by 3
- K011157: Cook Ivf Cryopreservation Kit and the Cook Ivf Thaw Kit (2001), cited by 3

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