510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K240127Substantially Equivalent

PlumeSafe X5 Smoke Management System

ConMed Corporation, Greenwood Village CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K240127 is the FDA 510(k) clearance record for PlumeSafe X5 Smoke Management System, a class II device, cleared for Conmed Corporation on under FDA product code FYD (Apparatus, Exhaust, Surgical). FDA records list 84 510(k) clearances for Conmed Corporation, from to . As of , FDA records show no recalls naming K240127.

Clearance record

Decision date
Received
(201 days to decision)
Product code
FYD Apparatus, Exhaust, Surgical
Regulation
21 CFR 878.5070
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Conmed Corporation 6455 S. Yosemite St., Greenwood Village CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FYD

Trailing 12 months

FDA records hold no clearances under product code FYD in the trailing twelve months.

FDA records show no clearances under product code FYD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FYD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260