Cleared Traditional

K904138 - SMART SCALE X-RAY PLATFORM

K904138 is an FDA 510(k) clearance for SMART SCALE X-RAY PLATFORM, 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 74-day FDA review.

K904138 · Olympic Medical Corp. · General Hospital
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Nov 1990
Decision
74d
Days
Class 1
Risk

K904138 is an FDA 510(k) clearance for the SMART SCALE X-RAY PLATFORM. 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 November 19, 1990 after a review of 74 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 Olympic Medical Corp. devices

FDA 510(k) Submission Details - K904138

510(k) Number K904138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1990
Decision Date November 19, 1990
Days to Decision 74 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 129d · This submission: 74d
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 14
Devices cleared under the same product code (FRW) and FDA review panel - the closest regulatory comparables to K904138.
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
DISETRONIC DOLOMAT PUMP
K920063 · Disetronic Medical Systems · Aug 1993
VAAKA BABY SCALE
K902545 · Ferguson Medical · Jul 1990
OLYMPIC SMART SCALE PEDIATRICS MODEL 50
K901522 · Olympic Medical Corp. · Jun 1990
OLYMPIC SMART SCALE
K871104 · Olympic Medical Corp. · May 1987