Cleared Traditional

K902545 - VAAKA BABY SCALE (FDA 510(k) Clearance)

Class I General Hospital device.

K902545 · Ferguson Medical · General Hospital
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Jul 1990
Decision
48d
Days
Class 1
Risk

K902545 is an FDA 510(k) clearance for the VAAKA BABY SCALE. Classified as Scale, Patient (product code FRW), Class I - General Controls.

Submitted by Ferguson Medical (Chico, US). The FDA issued a Cleared decision on July 26, 1990 after a review of 48 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 Ferguson Medical devices

Submission Details

510(k) Number K902545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1990
Decision Date July 26, 1990
Days to Decision 48 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
80d faster than avg
Panel avg: 128d · This submission: 48d
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.