Cleared Traditional

J&S PEDIATRIC IRON SATURATING REAGENT (K910672) - FDA 510(k) Clearance

Class I Chemistry device.

K910672 · J.S. Medical Assoc. · Chemistry device
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Apr 1991
Decision
73d
Days
Class 1
Risk

K910672 is an FDA 510(k) clearance for the J&S PEDIATRIC IRON SATURATING REAGENT. Classified as Resin, Ion-exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity (product code JQE), Class I - General Controls.

Submitted by J.S. Medical Assoc. (Natick, US). The FDA issued a Cleared decision on April 29, 1991 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1415 - the FDA in vitro diagnostics and chemistry 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 J.S. Medical Assoc. devices

Submission Details

510(k) Number K910672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1991
Decision Date April 29, 1991
Days to Decision 73 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 88d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQE Resin, Ion-exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1415
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.