Cleared Traditional

MODEL 9100 H.R. INFANT SCALE (K926174) - FDA 510(k) Clearance

Class I General Hospital device.

K926174 · Acme Medical Scale Co. · General Hospital
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Oct 1993
Decision
321d
Days
Class 1
Risk

K926174 is an FDA 510(k) clearance for the MODEL 9100 H.R. INFANT SCALE. Classified as Scale, Patient (product code FRW), Class I - General Controls.

Submitted by Acme Medical Scale Co. (San Leandro, US). The FDA issued a Cleared decision on October 25, 1993 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Acme Medical Scale Co. devices

Submission Details

510(k) Number K926174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1992
Decision Date October 25, 1993
Days to Decision 321 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
192d slower than avg
Panel avg: 129d · This submission: 321d
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.