# K220760: Pre-Formed Penile Silicone Block

- Pathway: 510(k) (Traditional)
- Applicant: International Medical Devices, Inc.
- Decided: May 13, 2022 after 59 days
- Product code: MIB (Elastomer, Silicone Block)
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K021839 (2002). 6 ancestors in all.
1 later device descends 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)
- K181387: Pre-Formed Penile Silicone Block, International Medical Devices, Inc. (2019) Summary page 4.

## Most influential descendants
- K223051: Pre-Formed Silicone Block (2023), 0 descendants of its own

## Indications for use
The Pre-Formed Penile Silicone Block is intended for use in augmentation, reconstructive and cosmetic surgery, and is contoured at the surgeon's discretion to create a custom implant. When used in augmentation procedures, the device provides cosmetic augmentation of the penis and is intended for aesthetic purposes.

Source page: https://510kreport.com/device/K220760
Methodology: https://510kreport.com/methodology