Cleared Traditional

SCALE-TRONIX PLATFORM SCALE (K912662) - FDA 510(k) Clearance

Class I General Hospital device.

K912662 · Scale-Tronix, Inc. · General Hospital
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Mar 1992
Decision
283d
Days
Class 1
Risk

K912662 is an FDA 510(k) clearance for the SCALE-TRONIX PLATFORM SCALE. Classified as Scale, Patient (product code FRW), Class I - General Controls.

Submitted by Scale-Tronix, Inc. (Wheaton, US). The FDA issued a Cleared decision on March 27, 1992 after a review of 283 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2720 - 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 Scale-Tronix, Inc. devices

Submission Details

510(k) Number K912662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1991
Decision Date March 27, 1992
Days to Decision 283 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
154d slower than avg
Panel avg: 129d · This submission: 283d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRW Scale, Patient
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2720
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.