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

Whole Room Microbial Reduction Device

21 CFR 880.6510 / General Hospital
FDA source (opens on fda.gov)

QXJ is the FDA product code for Whole Room Microbial Reduction Device, a class II device type, regulated under 21 CFR 880.6510. FDA's definition for this code 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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
QXJ
Device name
Whole Room Microbial Reduction Device
FDA definition
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.
Regulation
21 CFR 880.6510
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
1

Clearances, product code QXJ

By decision year
2 clearances under product code QXJ with a decision year between 2023 and 2025, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QXJ by decision year
YearClearances
20231
20251

Applicants with the most clearances

Product code QXJ
Applicants holding the most 510(k) clearances under product code QXJ
ApplicantClearances
Preventamed Technologies, Inc. dba Surfacide Manufacturing1
XENEX Disinfection Services Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code