Cleared Traditional

K952649 - WARM-SCALE

K952649 is an FDA 510(k) clearance for WARM-SCALE, 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 67-day FDA review.

K952649 · Olympic Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
67d
Days
Class 1
Risk

K952649 is an FDA 510(k) clearance for the WARM-SCALE. 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 August 15, 1995 after a review of 67 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 - K952649

510(k) Number K952649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1995
Decision Date August 15, 1995
Days to Decision 67 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
62d faster than avg
Panel avg: 129d · This submission: 67d
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 K952649.
OLYMPIC SMART SCALE MODEL 50/50RA
K955357 · Olympic Medical Corp. · Jan 1996
OLYMPIC SMART SCALE
K954846 · Olympic Medical Corp. · Dec 1995
OLYMPIC SMART SCALE
K955177 · Olympic Medical Corp. · Dec 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
DISETRONIC DOLOMAT PUMP
K920063 · Disetronic Medical Systems · Aug 1993