Cleared Traditional

Pre-Formed Silicone Block (K223051) - FDA 510(k) Clearance

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

K223051 · International Medical Devices, Inc. · General & Plastic Surgery device
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Feb 2023
Decision
127d
Days
Class 2
Risk

K223051 is an FDA 510(k) clearance for the Pre-Formed 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 February 3, 2023 after a review of 127 days - within the typical 510(k) review window.

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 K223051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2022
Decision Date February 03, 2023
Days to Decision 127 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
12d slower than avg
Panel avg: 115d · This submission: 127d
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 Consultant

RQM+
Lucie Dalet

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 7
Devices cleared under the same product code (MIB) and FDA review panel - the closest regulatory comparables to K223051.
MISTI Silicone Implant
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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
BioSiCar Silicone Implant
K193392 · Metalware Technology Corp. · Jul 2020
Pre-Formed Penile Silicone Block
K181387 · International Medical Devices, Inc. · Jan 2019