Cleared Traditional

K181387 - Pre-Formed Penile Silicone Block

K181387 is an FDA 510(k) clearance for Pre-Formed Penile Silicone Block, manufactured by International Medical Devices, Inc.. The device is a Class 2 General & Plastic Surgery device with product code MIB cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K181387 · International Medical Devices, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K181387

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 115d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MIB Device Classification - Class 2, Special Controls

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 Consultant

Acknowledge Regulatory Strategies, LLC
Allison Komiyama

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MIB Elastomer, Silicone Block

All 10
Devices cleared under the same product code (MIB) and FDA review panel - the closest regulatory comparables to K181387.
AugMENTA Penile Implant
K200073 · Augmenta, LLC · Sep 2022
Pre-Formed Penile Silicone Block
K220760 · International Medical Devices, Inc. · May 2022
BioSiCar Silicone Implant
K193392 · Metalware Technology Corp. · Jul 2020
SOFTXIL
K171851 · Bistool · Mar 2018
GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X
K052504 · Implantech Associates, Inc. · Nov 2005
CALF IMPLANT, MODEL EC17-X
K052505 · Implantech Associates, Inc. · Nov 2005