Cleared Traditional

K033381 - DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL

K033381 is an FDA 510(k) clearance for DISCHEM CHEMICAL PROPORTIONING & DISPEN..., manufactured by Discus Dental, Inc.. The device is a Class 2 General Hospital device with product code MED cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K033381 · Discus Dental, Inc. · General Hospital
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Jan 2004
Decision
97d
Days
Class 2
Risk

K033381 is an FDA 510(k) clearance for the DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G C.... Classified as Sterilant, Medical Devices (product code MED), Class II - Special Controls.

Submitted by Discus Dental, Inc. (Culver City, US). The FDA issued a Cleared decision on January 27, 2004 after a review of 97 days - within the typical 510(k) review window.

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.

View all Discus Dental, Inc. devices

FDA 510(k) Submission Details - K033381

510(k) Number K033381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2003
Decision Date January 27, 2004
Days to Decision 97 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 129d · This submission: 97d
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 41
Devices cleared under the same product code (MED) and FDA review panel - the closest regulatory comparables to K033381.
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K993042 · Medivators, Inc. · Aug 2000