Cleared Traditional

K934666 - PDS ULTRACLEAN

K934666 is an FDA 510(k) clearance for PDS ULTRACLEAN, manufactured by Medical Polymers, Inc.. The device is a Class 1 General Hospital device with product code FLG cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K934666 · Medical Polymers, Inc. · General Hospital
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Apr 1994
Decision
199d
Days
Class 1
Risk

K934666 is an FDA 510(k) clearance for the PDS ULTRACLEAN. Classified as Cleaner, Ultrasonic, Medical Instrument (product code FLG), Class I - General Controls.

Submitted by Medical Polymers, Inc. (Austin, US). The FDA issued a Cleared decision on April 15, 1994 after a review of 199 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6150 - 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 Medical Polymers, Inc. devices

FDA 510(k) Submission Details - K934666

510(k) Number K934666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1993
Decision Date April 15, 1994
Days to Decision 199 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
70d slower than avg
Panel avg: 129d · This submission: 199d
Pathway characteristics
Predicate-based equivalence.

FLG Device Classification - Class 1, General Controls

Product Code FLG Cleaner, Ultrasonic, Medical Instrument
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6150
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FLG Cleaner, Ultrasonic, Medical Instrument

Devices cleared under the same product code (FLG) and FDA review panel - the closest regulatory comparables to K934666.
ALSA-KLENZ
K944494 · Calgon Vestal Div. · Oct 1994
BILL EVANS-KLENZ
K944033 · Calgon Vestal Div. · Oct 1994
MON-KLENZ
K941163 · Calgon Vestal Div. · May 1994
SURGICLEAN ENZYMATIC INSTRUMENT CLEANER
K931270 · Surgicot, Inc. · Apr 1994
INSTRUMENT DETERGENT CONCENTRATE
K933149 · Nobelpharma USA, Inc. · Feb 1994
UCS-2, ULTRASONIC CLEANING SOLUTION
K861147 · Keymed, Inc. · Jun 1986