# K203229: NATRELLE INSPIRA Single Use Sizers for Gel Implants

- Pathway: 510(k) (Special)
- Applicant: Allergan
- Decided: Jun 2, 2021 after 212 days
- Product code: MRD (Mammary Sizer)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K831566 (1983). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831566: Cui Mammary Prothesis Sizer, Cox-Uphuff Intl. (1983) Summary page 4.

## Indications for use
NATRELLE INSPIRA® Single Use Sizers are used during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size breast implant.

Source page: https://510kreport.com/device/K203229
Methodology: https://510kreport.com/methodology