Cleared Traditional

K253267 - CORIS System (FDA 510(k) Clearance)

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

K253267 · Nanosonics Limited · General Hospital
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Optimized for regulatory review, auditing and printing
Mar 2026
Decision
157d
Days
Class 2
Risk

K253267 is an FDA 510(k) clearance for the CORIS System. Classified as Automated Endoscope Channel Cleaner (product code SEW), Class II - Special Controls.

Submitted by Nanosonics Limited (Macquarie Park, AU). The FDA issued a Cleared decision on March 5, 2026 after a review of 157 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6994 - 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.

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Submission Details

510(k) Number K253267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2025
Decision Date March 05, 2026
Days to Decision 157 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
29d slower than avg
Panel avg: 128d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SEW Automated Endoscope Channel Cleaner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6994
Definition An Automated Endoscope Channel Cleaner Is A Device Intended To Replace All Or A Portion Of Manual Cleaning Of Internal Passages And Ports Of Compatible Reusable Flexible Endoscopes. Cleaning Is Conducted Using An Agent That Exerts Physical Force (e.g., Friction) On Single Or Multiple Channels Of Compatible Endoscopes For Removal Of Soil. This Device Type Is Not Intended To Provide Or Replace High-level Disinfection Or Sterilization.
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.