Cleared Traditional

SHAPE-ACTIO METAL TOXICOLOGY CONTROL (K863915) - FDA 510(k) Clearance

Class I Toxicology device.

K863915 · Shape Products Co. · Toxicology device
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Nov 1986
Decision
47d
Days
Class 1
Risk

K863915 is an FDA 510(k) clearance for the SHAPE-ACTIO METAL TOXICOLOGY CONTROL. Classified as Heavy Metals Control Materials (product code DIE), Class I - General Controls.

Submitted by Shape Products Co. (Oakland, US). The FDA issued a Cleared decision on November 24, 1986 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - the FDA toxicology 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 Shape Products Co. devices

Submission Details

510(k) Number K863915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1986
Decision Date November 24, 1986
Days to Decision 47 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 87d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIE Heavy Metals Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
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.