# MRX: System, Assisted Reproduction Laser

- Device class: 2; regulation: 21 CFR 884.6200; FDA's rule: 510(k) required
- FDA decisions: 11
- 510(k) review time 2021–2025: median 326 days (middle half 326–326)
- Recalls: 0 (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)
- 2004: 1
- 2005: 1
- 2006: 1
- 2007: 2
- 2009: 1
- 2012: 1
- 2015: 1
- 2020: 1
- 2021: 1
- 2026: 1

## Most-cited predicates
- K141434: Saturn 5 Laser (2015), cited by 3
- K060764: Saturn 3 Laser System (2007), cited by 3
- DEN040009: Hamilton Thorne Zona Infrared Laser Optical System (Zilos TK) (2004), cited by 2
- K083208: Saturn Active Laser System (2009), cited by 1
- K063636: Zilos-TK (2007), cited by 1
- K050768: Zilos-TK, Version 3, Zilos-TK, Version 4 (2005), cited by 1

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