Cleared Traditional

K254094 - Endox High Level Disinfectant

K254094 is an FDA 510(k) clearance for Endox High Level Disinfectant, manufactured by Whiteley USA, Inc.. The device is a Class 2 General Hospital device with product code MED cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K254094 · Whiteley USA, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
301d
Days
Class 2
Risk

K254094 is an FDA 510(k) clearance for the Endox High Level Disinfectant. Classified as Sterilant, Medical Devices (product code MED), Class II - Special Controls.

Submitted by Whiteley USA, Inc. (Wilmington, US). The FDA issued a Cleared decision on October 16, 2026 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6885 - 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. Elevated predicate reliance profile. 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.

FDA 510(k) Submission Details - K254094

510(k) Number K254094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2025
Decision Date October 16, 2026
Days to Decision 301 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
172d slower than avg
Panel avg: 129d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MED Device Classification - Class 2, Special Controls

Product Code MED Sterilant, Medical Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6885
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.

Regulatory Peers - MED Sterilant, Medical Devices

All 64
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K210737 · STERIS Corporation · May 2021
K254094 · Endox High Level Disinfectant
Download PDF FDA Summary Whiteley USA, Inc.