510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN210004Unknown

Zuno Smart Sterilization Container

Zuno Medical, Inc., Campbell CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN210004 is the FDA 510(k) clearance record for Zuno Smart Sterilization Container, a class II device, cleared for Zuno Medical, Inc. on under FDA product code QJT (Rigid Sterilization Container With Software). FDA's definition for product code QJT reads: "The rigid sterilization container with software is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device(s) and to...". FDA records list one 510(k) clearance for Zuno Medical, Inc. As of , FDA records show no recalls naming DEN210004.

Clearance record

Decision date
Received
(486 days to decision)
Product code
QJT Rigid Sterilization Container With Software
Regulation
21 CFR 880.6855
Device class
Class II
Review panel
General Hospital
Applicant
Zuno Medical, Inc. 743 Camden Ave., Suite B, Campbell CA
Third party review
No

Clearances, product code QJT

Trailing 12 months

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

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