Cleared Traditional

SafeAir Smoke Evacuator compact (K182224) - FDA 510(k) Clearance

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

K182224 · Lina Medical Aps · General Hospital
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Feb 2019
Decision
175d
Days
Class 2
Risk

K182224 is an FDA 510(k) clearance for the SafeAir Smoke Evacuator compact. Classified as Apparatus, Exhaust, Surgical (product code FYD), Class II - Special Controls.

Submitted by Lina Medical Aps (Tarnowo Podgorne, PL). The FDA issued a Cleared decision on February 7, 2019 after a review of 175 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 Lina Medical Aps devices

Submission Details

510(k) Number K182224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2018
Decision Date February 07, 2019
Days to Decision 175 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
46d slower than avg
Panel avg: 129d · This submission: 175d
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 Consultant

Kevin F. Macdonald
Kevin F. MacDonald

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FYD Apparatus, Exhaust, Surgical

All 10
Devices cleared under the same product code (FYD) and FDA review panel - the closest regulatory comparables to K182224.
Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor
K200250 · Megadyne Medical Products, Inc. · Jun 2020
EvaQMax Smoke Evacuation System
K192035 · Bio Protech, Inc. · Aug 2019
Megadyne Foot Switch
K191328 · Megadyne Medical Products, Inc. · Jul 2019
Smoklean
K173108 · Sejong Medical Co., Ltd. · May 2018
RapidVac Smoke Evacuator System
K142335 · Covidien · Jan 2015
STERIS SMOKE EVACUATION SYSTEM
K991167 · STERIS Corporation · Jun 1999