Cleared Traditional

K041360 - ALDAHOL III HIGH-LEVEL DISINFECTANT

K041360 is an FDA 510(k) clearance for ALDAHOL III HIGH-LEVEL DISINFECTANT, manufactured by Healthpoint, Ltd.. The device is a Class 2 General Hospital device with product code MED cleared through the Traditional 510(k) pathway after a 349-day FDA review.

K041360 · Healthpoint, Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
May 2005
Decision
349d
Days
Class 2
Risk

K041360 is an FDA 510(k) clearance for the ALDAHOL III HIGH-LEVEL DISINFECTANT. Classified as Sterilant, Medical Devices (product code MED), Class II - Special Controls.

Submitted by Healthpoint, Ltd. (Euless, US). The FDA issued a Cleared decision on May 5, 2005 after a review of 349 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.

View all Healthpoint, Ltd. devices

FDA 510(k) Submission Details - K041360

510(k) Number K041360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2004
Decision Date May 05, 2005
Days to Decision 349 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
220d slower than avg
Panel avg: 129d · This submission: 349d
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 31
Devices cleared under the same product code (MED) and FDA review panel - the closest regulatory comparables to K041360.
MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT
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SYSTEM 1.5 STERILE PROCESSING SYSTEM
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RESERT XL HLD HIGH LEVEL DISINFECTANT
K080420 · STERIS Corporation · Sep 2008
CIDEX OPA CONCENTRATE
K032959 · Advanced Sterilization Products · Apr 2005
0.55% ORTH-PHTHALALDEHYDE SOLUTION
K030004 · Advanced Sterilization Products · Feb 2003
CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)
K002401 · Advanced Sterilization Products · Aug 2000