Cleared Traditional

K222748 - ShiNeo Silicone Implant

K222748 is an FDA 510(k) clearance for ShiNeo Silicone Implant, manufactured by Shineo Technology Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code MIB cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K222748 · Shineo Technology Co., Ltd. · General & Plastic Surgery device
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Dec 2022
Decision
102d
Days
Class 2
Risk

K222748 is an FDA 510(k) clearance for the ShiNeo Silicone Implant. Classified as Elastomer, Silicone Block (product code MIB), Class II - Special Controls.

Submitted by Shineo Technology Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on December 23, 2022 after a review of 102 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 Shineo Technology Co., Ltd. devices

FDA 510(k) Submission Details - K222748

510(k) Number K222748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2022
Decision Date December 23, 2022
Days to Decision 102 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
13d faster than avg
Panel avg: 115d · This submission: 102d
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 Peers - MIB Elastomer, Silicone Block

All 10
Devices cleared under the same product code (MIB) and FDA review panel - the closest regulatory comparables to K222748.
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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