Cleared Traditional

WECK INSTRUMENT CLEANER, CAT. NO. 850-103 (K861588) - FDA 510(k) Clearance

Class I General Hospital device.

K861588 · Palmetto Chemical & Supply Co., Inc. · General Hospital
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Jun 1986
Decision
49d
Days
Class 1
Risk

K861588 is an FDA 510(k) clearance for the WECK INSTRUMENT CLEANER, CAT. NO. 850-103. Classified as Cleaner, Ultrasonic, Medical Instrument (product code FLG), Class I - General Controls.

Submitted by Palmetto Chemical & Supply Co., Inc. (Monroe, US). The FDA issued a Cleared decision on June 17, 1986 after a review of 49 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 Palmetto Chemical & Supply Co., Inc. devices

Submission Details

510(k) Number K861588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1986
Decision Date June 17, 1986
Days to Decision 49 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 129d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.