# MRD: Mammary Sizer

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 13
- 510(k) review time 2021–2025: median 98 days (middle half 94–155)
- 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)
- 1999: 1
- 2001: 1
- 2006: 1
- 2013: 1
- 2015: 1
- 2019: 1
- 2020: 1
- 2021: 1
- 2024: 1
- 2025: 1

## Most-cited predicates
- K131853: Mentor Memoryshape Resterilizable Gel Sizer (2013), cited by 2
- K151055: Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE (2015), cited by 2
- K062421: Mentor Resterilizable Gel Breast Implant Sizer (2006), cited by 2
- K010709: Mentor Sterile Saline Mammary Volume Sizers (2001), cited by 1
- K183163: Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix (2019), cited by 1
- K241552: MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (2024), cited by 1
- K831566: Cui Mammary Prothesis Sizer (1983), cited by 1

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