Cleared Traditional

K955357 - OLYMPIC SMART SCALE MODEL 50/50RA (FDA 510(k) Clearance)

Class I General Hospital device.

K955357 · Olympic Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
99d
Days
Class 1
Risk

K955357 is an FDA 510(k) clearance for the OLYMPIC SMART SCALE MODEL 50/50RA. Classified as Scale, Patient (product code FRW), Class I - General Controls.

Submitted by Olympic Medical Corp. (Seattle, US). The FDA issued a Cleared decision on January 30, 1996 after a review of 99 days - within the typical 510(k) review window.

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 Olympic Medical Corp. devices

Submission Details

510(k) Number K955357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1995
Decision Date January 30, 1996
Days to Decision 99 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 128d · This submission: 99d
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.