# K010709: Mentor Sterile Saline Mammary Volume Sizers

- Pathway: 510(k) (Traditional)
- Applicant: Mentor Corp.
- Decided: Apr 23, 2001 after 45 days
- Product code: MRD (Mammary Sizer)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K062421: Mentor Resterilizable Gel Breast Implant Sizer (2006), 6 descendants of its own
- K131853: Mentor Memoryshape Resterilizable Gel Sizer (2013), 4 descendants of its own
- K151055: Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE (2015), 3 descendants of its own
- K241552: MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (2024), 1 descendant of its own
- K183163: Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix (2019), 1 descendant of its own

## Recalls of this device
- Jul 2, 2014 · Class II · Z-2591-2014: The device labeling is stamped with 330cc and the device is actually 380cc device.

Source page: https://510kreport.com/device/K010709
Methodology: https://510kreport.com/methodology