Cleared Traditional

K872524 - SAFEWEIGH MAGIC SCALE

K872524 is the FDA 510(k) clearance for SAFEWEIGH MAGIC SCALE by Health Care Innovations, Inc.. It is a Class 1 General Hospital device (product code FRW) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K872524 · Health Care Innovations, Inc. · General Hospital
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Oct 1987
Decision
106d
Days
Class 1
Risk

K872524 is an FDA 510(k) clearance for the SAFEWEIGH MAGIC SCALE. Classified as Scale, Patient (product code FRW), Class I - General Controls.

Submitted by Health Care Innovations, Inc. (Elyria, US). The FDA issued a Cleared decision on October 9, 1987 after a review of 106 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 Health Care Innovations, Inc. devices

Submission Details

510(k) Number K872524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1987
Decision Date October 09, 1987
Days to Decision 106 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
23d faster than avg
Panel avg: 129d · This submission: 106d
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.

Regulatory Peers - FRW Scale, Patient

All 13
Devices cleared under the same product code (FRW) and FDA review panel - the closest regulatory comparables to K872524.
SMART SCALE X-RAY PLATFORM
K904138 · Olympic Medical Corp. · Nov 1990
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
WARM WEIGH MODEL N-10 INFANT SCALE
K870888 · Air-Shields, Inc. · Mar 1987
MODEL 304-S EXTERNAL MICRO-VOLUME INFUSION PUMP
K864327 · Medtronic Minimed · Feb 1987