Cleared Traditional

K200250 - Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor

K200250 is an FDA 510(k) clearance for Megadyne Smoke Evacuator, manufactured by Megadyne Medical Products, Inc.. The device is a Class 2 General Hospital device with product code FYD cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K200250 · Megadyne Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
144d
Days
Class 2
Risk

K200250 is an FDA 510(k) clearance for the Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Conn.... Classified as Apparatus, Exhaust, Surgical (product code FYD), Class II - Special Controls.

Submitted by Megadyne Medical Products, Inc. (Draper, US). The FDA issued a Cleared decision on June 26, 2020 after a review of 144 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 Megadyne Medical Products, Inc. devices

FDA 510(k) Submission Details - K200250

510(k) Number K200250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2020
Decision Date June 26, 2020
Days to Decision 144 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
15d slower than avg
Panel avg: 129d · This submission: 144d
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 Consultant

Ethicon Endo-Surgery, Inc.
Kweku Biney

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 48
Devices cleared under the same product code (FYD) and FDA review panel - the closest regulatory comparables to K200250.
8Q10 Surclear Smoke Plume Evacuation System
K233789 · Surnic Corporation · Apr 2024
Medline Smoke Evacuation Shroud
K213068 · Medline Industries, Inc. · Jan 2022
NEBULAE SRS Laparoscopic Surgical Smoke Removal System
K202944 · Northgate Technologies, Inc. · Mar 2021
EvaQMax Smoke Evacuation System
K192035 · Bio Protech, Inc. · Aug 2019
Megadyne Foot Switch
K191328 · Megadyne Medical Products, Inc. · Jul 2019
SafeAir Smoke Evacuator compact
K182224 · Lina Medical Aps · Feb 2019