# K831566: Cui Mammary Prothesis Sizer

- Pathway: 510(k) (Traditional)
- Applicant: Cox-Uphuff Intl.
- Decided: Aug 12, 1983 after 88 days
- Product code: MRD (Mammary Sizer)
- Device class: U
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K203229: NATRELLE INSPIRA Single Use Sizers for Gel Implants (2021), 0 descendants of its own

## Recalls of this device
- Nov 6, 2019 · Class III · Z-0702-2020: The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string
- Jun 8, 2015 · Class II · Z-1988-2015: Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level.

Source page: https://510kreport.com/device/K831566
Methodology: https://510kreport.com/methodology