Cleared Traditional

K943587 - ADVANCED IN-BED WEIGH SYSTEM

K943587 is an FDA 510(k) clearance for ADVANCED IN-BED WEIGH SYSTEM, manufactured by Future Systems, Inc.. The device is a Class 1 General Hospital device with product code FRW cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K943587 · Future Systems, Inc. · General Hospital
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Sep 1994
Decision
62d
Days
Class 1
Risk

K943587 is an FDA 510(k) clearance for the ADVANCED IN-BED WEIGH SYSTEM. Classified as Scale, Patient (product code FRW), Class I - General Controls.

Submitted by Future Systems, Inc. (Chicago, US). The FDA issued a Cleared decision on September 22, 1994 after a review of 62 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 Future Systems, Inc. devices

FDA 510(k) Submission Details - K943587

510(k) Number K943587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1994
Decision Date September 22, 1994
Days to Decision 62 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 129d · This submission: 62d
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 15
Devices cleared under the same product code (FRW) and FDA review panel - the closest regulatory comparables to K943587.
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
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3M MODEL 200RT RATE TAPER INFUSION PUMP
K926059 · 3M Health Care, Ltd. · Aug 1993
DISETRONIC DOLOMAT PUMP
K920063 · Disetronic Medical Systems · Aug 1993