FYD · Class II · 21 CFR 878.5070

FDA Product Code FYD: Apparatus, Exhaust, Surgical

Smoke evacuation in the operating room protects surgical team members from toxic surgical plume. FDA product code FYD covers surgical exhaust apparatus used to capture and filter electrosurgical and laser smoke.

These devices use suction and filtration to capture surgical plume at the source, preventing inhalation of particulates, viable cellular material, and toxic chemicals released during electrosurgery, laser procedures, and powered bone cutting.

FYD devices are Class II medical devices, regulated under 21 CFR 878.5070 and reviewed by the FDA General Hospital panel.

Leading manufacturers include Megadyne Medical Products, Inc., Conmed Corporation and Covidien.

75
Total
75
Cleared
194d
Avg days
1985
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Apparatus, Exhaust, Surgical Devices (Product Code FYD)

75 devices
1–24 of 75
Cleared Aug 05, 2024
PlumeSafe X5 Smoke Management System
K240127
Conmed Corporation
General Hospital · 201d
Cleared Apr 10, 2024
8Q10 Surclear Smoke Plume Evacuation System
K233789
Surnic Corporation
General Hospital · 134d
Cleared Jan 03, 2022
Medline Smoke Evacuation Shroud
K213068
Medline Industries, Inc.
General Hospital · 102d
Cleared Mar 25, 2021
NEBULAE SRS Laparoscopic Surgical Smoke Removal System
K202944
Northgate Technologies, Inc.
General Hospital · 176d
Cleared Jun 26, 2020
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.
General Hospital · 144d
Cleared Aug 29, 2019
EvaQMax Smoke Evacuation System
K192035
Bio Protech, Inc.
General Hospital · 30d
Cleared Jul 26, 2019
Megadyne Foot Switch
K191328
Megadyne Medical Products, Inc.
General Hospital · 71d
Cleared Feb 07, 2019
SafeAir Smoke Evacuator compact
K182224
Lina Medical Aps
General Hospital · 175d
Cleared May 18, 2018
Smoklean
K173108
Sejong Medical Co., Ltd.
General Hospital · 231d
Cleared Jan 14, 2015
RapidVac Smoke Evacuator System
K142335
Covidien
General Hospital · 146d
Cleared May 05, 2009
CONMED AER DEFENSE SMOKE EVACUATOR
K091139
Conmed Corporation
General Hospital · 15d
Cleared Nov 29, 2001
NEPTUNE WASTE MANAGEMENT STSTEM
K012991
Stryker Instruments
General Hospital · 84d
Cleared Jun 03, 1999
STERIS SMOKE EVACUATION SYSTEM
K991167
STERIS Corporation
General Hospital · 57d
Cleared Jun 29, 1998
VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM
K980915
Valleylab, Inc.
General Hospital · 110d
Cleared Aug 28, 1995
FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC
K952981
Utah Medical Products, Inc.
General Hospital · 61d

About Product Code FYD - Regulatory Context

510(k) Submission Activity

75 total 510(k) submissions under product code FYD since 1985, with 75 receiving FDA clearance (average review time: 194 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.