Not Cleared Direct

DEN220041 - Tristel Duo ULT (FDA 510(k) Clearance)

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

DEN220041 · Tristel Solutions Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
338d
Days
Class 2
Risk

DEN220041 is an FDA 510(k) submission (not cleared) for the Tristel Duo ULT. Classified as Foam Or Gel Chemical Sterilant/high Level Disinfectant (product code QWS), Class II - Special Controls.

Submitted by Tristel Solutions Limited (Snailwell, GB). The FDA issued a Not Cleared (DENG) decision on June 2, 2023 after a review of 338 days.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6886 - 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 338 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 Tristel Solutions Limited devices

Submission Details

510(k) Number DEN220041 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 29, 2022
Decision Date June 02, 2023
Days to Decision 338 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
210d slower than avg
Panel avg: 128d · This submission: 338d
Pathway characteristics

Device Classification

Product Code QWS Foam Or Gel Chemical Sterilant/high Level Disinfectant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6886
Definition A Foam Or Gel Chemical Sterilant/high Level Disinfectant Is A Germicide In The Form Of A Foam Or Gel That Is Intended For Use As The Terminal Step In High Level Disinfection Of Medical Devices Prior To Patient Use.
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.