Cleared Traditional

K160988 - Biopor

K160988 is an FDA 510(k) clearance for Biopor, manufactured by Ceremed , Inc.. The device is a Class 2 General & Plastic Surgery device with product code KKY cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K160988 · Ceremed , Inc. · General & Plastic Surgery device
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Jul 2016
Decision
97d
Days
Class 2
Risk

K160988 is an FDA 510(k) clearance for the Biopor, AOC Porous Polyethylene, Cerepor. Classified as Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (product code KKY), Class II - Special Controls.

Submitted by Ceremed , Inc. (Los Angeles, US). The FDA issued a Cleared decision on July 14, 2016 after a review of 97 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3500 - 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 Ceremed , Inc. devices

FDA 510(k) Submission Details - K160988

510(k) Number K160988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2016
Decision Date July 14, 2016
Days to Decision 97 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
18d faster than avg
Panel avg: 115d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKY Device Classification - Class 2, Special Controls

Product Code KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3500
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 - KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Devices cleared under the same product code (KKY) and FDA review panel - the closest regulatory comparables to K160988.
Longeviti PorousFit implant
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SURG. GOWN & DRAPE, LOW LINT TREATMENT
K781019 · Kimberly-Clark Corp. · Aug 1978