Cleared Traditional

K242732 - Tristel OPH (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242732 · Tristel Solutions , Ltd. · General Hospital
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May 2025
Decision
241d
Days
Class 2
Risk

K242732 is an FDA 510(k) clearance for the Tristel OPH. Classified as Foam Or Gel Chemical Sterilant/high Level Disinfectant (product code QWS), Class II - Special Controls.

Submitted by Tristel Solutions , Ltd. (Cambridgeshire, GB). The FDA issued a Cleared decision on May 9, 2025 after a review of 241 days - an extended review cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Tristel Solutions , Ltd. devices

Submission Details

510(k) Number K242732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2024
Decision Date May 09, 2025
Days to Decision 241 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 128d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.