Cleared Traditional

BioSiCar Silicone Implant (K193392) - FDA 510(k) Clearance

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

K193392 · Metalware Technology Corp. · General & Plastic Surgery device
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Jul 2020
Decision
227d
Days
Class 2
Risk

K193392 is an FDA 510(k) clearance for the BioSiCar Silicone Implant. Classified as Elastomer, Silicone Block (product code MIB), Class II - Special Controls.

Submitted by Metalware Technology Corp. (New Taipei City, TW). The FDA issued a Cleared decision on July 20, 2020 after a review of 227 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 Metalware Technology Corp. devices

Submission Details

510(k) Number K193392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2019
Decision Date July 20, 2020
Days to Decision 227 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
112d slower than avg
Panel avg: 115d · This submission: 227d
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 K193392.
MISTI Silicone Implant
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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
Pre-Formed Penile Silicone Block
K181387 · International Medical Devices, Inc. · Jan 2019