510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN230067Unknown

Chronos®

Germitec, Bordeaux, FR / Direct, Unknown
FDA source (opens on fda.gov)

DEN230067 is the FDA 510(k) clearance record for Chronos®, a class II device, cleared for Germitec on under FDA product code SCS (Ultraviolet Radiation Disinfection Chamber Device). FDA's definition for product code SCS reads: "An ultraviolet radiation disinfection chamber device is intended to disinfect patient contacting medical devices using UV radiation after the device has been cleaned. Disinfection of the medical device is achieved within an enclosed...". FDA records list one 510(k) clearance for Germitec. As of , FDA records show no recalls naming DEN230067.

Clearance record

Decision date
Received
(335 days to decision)
Product code
SCS Ultraviolet Radiation Disinfection Chamber Device
Regulation
21 CFR 880.6511
Device class
Class II
Review panel
General Hospital
Applicant
Germitec 19 Rue Vauban, Bordeaux, FR
Third party review
No

Clearances, product code SCS

Trailing 12 months
1 clearance under product code SCS in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SCS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260