Cleared Traditional

K240127 - PlumeSafe X5 Smoke Management System

K240127 is an FDA 510(k) clearance for PlumeSafe X5 Smoke Management System, manufactured by Conmed Corporation. The device is a Class 2 General Hospital device with product code FYD cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K240127 · Conmed Corporation · General Hospital
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Aug 2024
Decision
201d
Days
Class 2
Risk

K240127 is an FDA 510(k) clearance for the PlumeSafe X5 Smoke Management System. Classified as Apparatus, Exhaust, Surgical (product code FYD), Class II - Special Controls.

Submitted by Conmed Corporation (Greenwood Village, US). The FDA issued a Cleared decision on August 5, 2024 after a review of 201 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 Conmed Corporation devices

FDA 510(k) Submission Details - K240127

510(k) Number K240127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2024
Decision Date August 05, 2024
Days to Decision 201 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
72d slower than avg
Panel avg: 129d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYD Device Classification - Class 2, Special Controls

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 46
Devices cleared under the same product code (FYD) and FDA review panel - the closest regulatory comparables to K240127.
8Q10 Surclear Smoke Plume Evacuation System
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K202944 · Northgate Technologies, Inc. · Mar 2021
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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