Cleared Traditional

K861147 - UCS-2, ULTRASONIC CLEANING SOLUTION (FDA 510(k) Clearance)

Class I General Hospital device.

K861147 · Keymed, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1986
Decision
89d
Days
Class 1
Risk

K861147 is an FDA 510(k) clearance for the UCS-2, ULTRASONIC CLEANING SOLUTION. Classified as Cleaner, Ultrasonic, Medical Instrument (product code FLG), Class I - General Controls.

Submitted by Keymed, Inc. (Essex Ss2 5qh England, GB). The FDA issued a Cleared decision on June 23, 1986 after a review of 89 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 Keymed, Inc. devices

Submission Details

510(k) Number K861147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1986
Decision Date June 23, 1986
Days to Decision 89 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
39d faster than avg
Panel avg: 128d · This submission: 89d
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.