# K042380: Silicone Block

- Pathway: 510(k) (Traditional)
- Applicant: National Medical Devices, Inc.
- Decided: Oct 25, 2004 after 54 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K162624: Pre-Formed Penile Silicone Block (2017), 4 descendants of its own
- K181387: Pre-Formed Penile Silicone Block (2019), 3 descendants of its own
- K220760: Pre-Formed Penile Silicone Block (2022), 1 descendant of its own
- K223051: Pre-Formed Silicone Block (2023), 0 descendants of its own
- K200073: AugMENTA Penile Implant (2022), 0 descendants of its own

## Indications for use
The Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process.

Source page: https://510kreport.com/device/K042380
Methodology: https://510kreport.com/methodology