Cleared Traditional

K944033 - BILL EVANS-KLENZ

K944033 is an FDA 510(k) clearance for BILL EVANS-KLENZ, manufactured by Calgon Vestal Div.. The device is a Class 1 General Hospital device with product code FLG cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K944033 · Calgon Vestal Div. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
51d
Days
Class 1
Risk

K944033 is an FDA 510(k) clearance for the BILL EVANS-KLENZ. Classified as Cleaner, Ultrasonic, Medical Instrument (product code FLG), Class I - General Controls.

Submitted by Calgon Vestal Div. (St. Louis, US). The FDA issued a Cleared decision on October 7, 1994 after a review of 51 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Calgon Vestal Div. devices

FDA 510(k) Submission Details - K944033

510(k) Number K944033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1994
Decision Date October 07, 1994
Days to Decision 51 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
78d faster than avg
Panel avg: 129d · This submission: 51d
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 K944033.
ALSA-KLENZ
K944494 · 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