Not Cleared Direct

DEN210004 - Zuno Smart Sterilization Container (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN210004 · Zuno Medical, Inc. · General Hospital
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Jun 2022
Decision
486d
Days
Class 2
Risk

DEN210004 is an FDA 510(k) submission (not cleared) for the Zuno Smart Sterilization Container. Classified as Rigid Sterilization Container With Software (product code QJT), Class II - Special Controls.

Submitted by Zuno Medical, Inc. (Campbell, US). The FDA issued a Not Cleared (DENG) decision on June 17, 2022 after a review of 486 days.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6855 - the FDA general hospital device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 486 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Zuno Medical, Inc. devices

Submission Details

510(k) Number DEN210004 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 16, 2021
Decision Date June 17, 2022
Days to Decision 486 days
Submission Type Direct
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
358d slower than avg
Panel avg: 128d · This submission: 486d
Pathway characteristics

Device Classification

Product Code QJT Rigid Sterilization Container With Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6855
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.