Cleared Traditional

K131402 - VISICLEAR SMOKE EVACUATION SYSTEM

K131402 is the FDA 510(k) clearance for VISICLEAR SMOKE EVACUATION SYSTEM by Buffalo Filter Co., Inc.. It is a Class 2 General Hospital device (product code FYD) cleared through the Traditional 510(k) pathway after a 292-day FDA review.

K131402 · Buffalo Filter Co., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
292d
Days
Class 2
Risk

K131402 is an FDA 510(k) clearance for the VISICLEAR SMOKE EVACUATION SYSTEM. Classified as Apparatus, Exhaust, Surgical (product code FYD), Class II - Special Controls.

Submitted by Buffalo Filter Co., Inc. (Lancaster, US). The FDA issued a Cleared decision on March 3, 2014 after a review of 292 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.5070 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Buffalo Filter Co., Inc. devices

Submission Details

510(k) Number K131402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2013
Decision Date March 03, 2014
Days to Decision 292 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 129d · This submission: 292d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FYD Apparatus, Exhaust, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5070
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 Hospital devices follow this clearance model.

Regulatory Peers - FYD Apparatus, Exhaust, Surgical

All 14
Devices cleared under the same product code (FYD) and FDA review panel - the closest regulatory comparables to K131402.
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CONMED AER DEFENSE SMOKE EVACUATOR
K091139 · Conmed Corporation · May 2009
NEPTUNE WASTE MANAGEMENT STSTEM
K012991 · Stryker Instruments · Nov 2001
STERIS SMOKE EVACUATION SYSTEM
K991167 · STERIS Corporation · Jun 1999