Cleared Traditional

K181387 - Pre-Formed Penile Silicone Block (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181387 · International Medical Devices, Inc. · General & Plastic Surgery device
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Jan 2019
Decision
243d
Days
Class 2
Risk

K181387 is an FDA 510(k) clearance for the Pre-Formed Penile Silicone Block. Classified as Elastomer, Silicone Block (product code MIB), Class II - Special Controls.

Submitted by International Medical Devices, Inc. (Beverly Hills, US). The FDA issued a Cleared decision on January 23, 2019 after a review of 243 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 874.3620 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all International Medical Devices, Inc. devices

Submission Details

510(k) Number K181387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2018
Decision Date January 23, 2019
Days to Decision 243 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 114d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MIB Elastomer, Silicone Block
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - MIB Elastomer, Silicone Block

All 44
Devices cleared under the same product code (MIB) and FDA review panel - the closest regulatory comparables to K181387.
MISTI Silicone Implant
K241150 · Keosan Trading Co. · Jul 2024
Pre-Formed Silicone Block
K223051 · International Medical Devices, Inc. · Feb 2023
ShiNeo Silicone Implant
K222748 · Shineo Technology Co., Ltd. · Dec 2022
AugMENTA Penile Implant
K200073 · Augmenta, LLC · Sep 2022
Pre-Formed Penile Silicone Block
K220760 · International Medical Devices, Inc. · May 2022