Cleared Traditional

K842754 - CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2

K842754 is an FDA 510(k) clearance for CUSTOM ULTRASONICS-SYS 80, manufactured by Custom Ultrasonics. The device is a Class 1 General Hospital device with product code FLG cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K842754 · Custom Ultrasonics · General Hospital
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Nov 1984
Decision
135d
Days
Class 1
Risk

K842754 is an FDA 510(k) clearance for the CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2. Classified as Cleaner, Ultrasonic, Medical Instrument (product code FLG), Class I - General Controls.

Submitted by Custom Ultrasonics (Buckingham, US). The FDA issued a Cleared decision on November 28, 1984 after a review of 135 days - within the typical 510(k) review window.

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 Custom Ultrasonics devices

FDA 510(k) Submission Details - K842754

510(k) Number K842754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1984
Decision Date November 28, 1984
Days to Decision 135 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
6d slower than avg
Panel avg: 129d · This submission: 135d
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.