Cleared Traditional

K142335 - RapidVac Smoke Evacuator System

K142335 is the FDA 510(k) clearance for RapidVac Smoke Evacuator System by Covidien. It is a Class 2 General Hospital device (product code FYD) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K142335 · Covidien · General Hospital
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Jan 2015
Decision
146d
Days
Class 2
Risk

K142335 is an FDA 510(k) clearance for the RapidVac Smoke Evacuator System. Classified as Apparatus, Exhaust, Surgical (product code FYD), Class II - Special Controls.

Submitted by Covidien (Mansfield, US). The FDA issued a Cleared decision on January 14, 2015 after a review of 146 days - within the typical 510(k) review window.

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 Covidien devices

Submission Details

510(k) Number K142335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2014
Decision Date January 14, 2015
Days to Decision 146 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 129d · This submission: 146d
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 13
Devices cleared under the same product code (FYD) and FDA review panel - the closest regulatory comparables to K142335.
Megadyne Foot Switch
K191328 · Megadyne Medical Products, Inc. · Jul 2019
SafeAir Smoke Evacuator compact
K182224 · Lina Medical Aps · Feb 2019
Smoklean
K173108 · Sejong Medical Co., Ltd. · May 2018
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