# K062421: Mentor Resterilizable Gel Breast Implant Sizer

- Pathway: 510(k) (Traditional)
- Applicant: Mentor Corporation
- Decided: Oct 10, 2006 after 53 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
Longest line of descent: 1 generation back to K010709 (2001). 1 ancestor in all.
6 later devices descend from it; 2 cite 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)
- K010709: Mentor Sterile Saline Mammary Volume Sizers, Mentor Corp. (2001)

## Most influential descendants
- 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
- K243271: MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (2025), 0 descendants of its own

## Recalls of this device
- Dec 11, 2014 · Class II · Z-0964-2015: The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect. Those units include the IFU for the MENTOR MemoryShape Resterilizable Sizer.

## Indications for use
The Mentor Resterilizable Gel Breast Implant Sizer is indicated for temporary insertion intraoperatively to evaluate the size and shape of the MemoryGel™ breast implant to be implanted.

Source page: https://510kreport.com/device/K062421
Methodology: https://510kreport.com/methodology