Cleared Traditional

K782084 - EMIT PROCAINAMIDE CONTROL SET

K782084 is the FDA 510(k) clearance for EMIT PROCAINAMIDE CONTROL SET by Syva Co.. It is a Class 1 Toxicology device (product code LAS) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K782084 · Syva Co. · Toxicology device
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Jan 1979
Decision
27d
Days
Class 1
Risk

K782084 is an FDA 510(k) clearance for the EMIT PROCAINAMIDE CONTROL SET. Classified as Drug Specific Control Materials (product code LAS), Class I - General Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on January 10, 1979 after a review of 27 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 Syva Co. devices

Submission Details

510(k) Number K782084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1978
Decision Date January 10, 1979
Days to Decision 27 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 87d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LAS Drug Specific 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.