Cleared Traditional

K955357 - OLYMPIC SMART SCALE MODEL 50/50RA

K955357 is an FDA 510(k) clearance for OLYMPIC SMART SCALE MODEL 50/50RA, manufactured by Olympic Medical Corp.. The device is a Class 1 General Hospital device with product code FRW cleared through the Traditional 510(k) pathway after a 99-day FDA review.

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

FDA 510(k) Submission Details - K955357

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 129d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

FRW Device Classification - Class 1, General Controls

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.

Regulatory Peers - FRW Scale, Patient

All 13
Devices cleared under the same product code (FRW) and FDA review panel - the closest regulatory comparables to K955357.
OLYMPIC SMART SCALE
K954846 · Olympic Medical Corp. · Dec 1995
OLYMPIC SMART SCALE
K955177 · Olympic Medical Corp. · Dec 1995
WARM-SCALE
K952649 · Olympic Medical Corp. · Aug 1995
3M MODEL 280RT RATE TAPER INFUSION PUMP
K926058 · 3M Health Care, Ltd. · Aug 1993
3M MODEL 200RT RATE TAPER INFUSION PUMP
K926059 · 3M Health Care, Ltd. · Aug 1993
SMART SCALE X-RAY PLATFORM
K904138 · Olympic Medical Corp. · Nov 1990