510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K242604Substantially Equivalent

Helios+ UV-C System

Preventamed Technologies, Inc. dba Surfacide Manufacturing, Waukesha WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K242604 is the FDA 510(k) clearance record for Helios+ UV-C System, a class II device, cleared for Preventamed Technologies, Inc. Dba Surfacide Manufacturing on under FDA product code QXJ (Whole Room Microbial Reduction Device). FDA's definition for product code QXJ reads: "A whole room microbial reduction device is a medical device to be used to reduce microbial load on medical device surfaces following cleaning and disinfection". FDA records list one 510(k) clearance for Preventamed Technologies, Inc. Dba Surfacide Manufacturing. As of , FDA records show no recalls naming K242604.

Clearance record

Decision date
Received
(270 days to decision)
Product code
QXJ Whole Room Microbial Reduction Device
Regulation
21 CFR 880.6510
Device class
Class II
Review panel
General Hospital
Applicant
Preventamed Technologies, Inc. Dba Surfacide Manufacturing W226n918 Northmound Dr., Suite 300, Waukesha WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QXJ

Trailing 12 months

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

FDA records show no clearances under product code QXJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QXJ, 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