Cleared Traditional

K041984 - ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT

K041984 is an FDA 510(k) clearance for ACECIDE HIGH-LEVEL DISINFECTANT AND STE..., manufactured by Best Sanitizers, Inc.. The device is a Class 2 General Hospital device with product code MED cleared through the Traditional 510(k) pathway after a 292-day FDA review.

K041984 · Best Sanitizers, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
292d
Days
Class 2
Risk

K041984 is an FDA 510(k) clearance for the ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT. Classified as Sterilant, Medical Devices (product code MED), Class II - Special Controls.

Submitted by Best Sanitizers, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 11, 2005 after a review of 292 days - an extended review cycle.

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. 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.

FDA 510(k) Submission Details - K041984

510(k) Number K041984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2004
Decision Date May 11, 2005
Days to Decision 292 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
163d slower than avg
Panel avg: 129d · This submission: 292d
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 62
Devices cleared under the same product code (MED) and FDA review panel - the closest regulatory comparables to K041984.
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K033381 · Discus Dental, Inc. · Jan 2004
K041984 · ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT
Download PDF FDA Summary Best Sanitizers, Inc.