QJT · Class II · 21 CFR 880.6855

FDA Product Code QJT: Rigid Sterilization Container With Software

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 Maintain Sterility Until Used. The Rigid Sterilization Container With Software Is Designed For Use With High-vacuum Or Pulse-vacuum Steam Sterilization Systems.

Leading manufacturers include Zuno Medical, Inc..

1
Total
0
Cleared
486d
Avg days
2022
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Rigid Sterilization Container With Software Devices (Product Code QJT)

1 devices
1–1 of 1
Not Cleared Jun 17, 2022
Zuno Smart Sterilization Container
DEN210004
Zuno Medical, Inc.
General Hospital · 486d

About Product Code QJT - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QJT since 2022, with 0 receiving FDA clearance (average review time: 486 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QJT devices are reviewed by the General Hospital panel. Browse all General Hospital devices →