Cleared Traditional

U.S. MEDICAL PS-2000 PEDIATRIC SCALE (K910582) - FDA 510(k) Clearance

Class I General Hospital device.

K910582 · U.S. Medical Corp. · General Hospital
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Mar 1991
Decision
38d
Days
Class 1
Risk

K910582 is an FDA 510(k) clearance for the U.S. MEDICAL PS-2000 PEDIATRIC SCALE. Classified as Scale, Patient (product code FRW), Class I - General Controls.

Submitted by U.S. Medical Corp. (Cheshire, US). The FDA issued a Cleared decision on March 21, 1991 after a review of 38 days - a notably fast clearance 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: 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 U.S. Medical Corp. devices

Submission Details

510(k) Number K910582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1991
Decision Date March 21, 1991
Days to Decision 38 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
91d faster than avg
Panel avg: 129d · This submission: 38d
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.